Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303470809477 Date of Approval: 03/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy, safety and tolerability of KLU156 in adults and children ≥ 5 kg body weight with uncomplicated P. falciparum malaria
Official scientific title A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment
Brief summary describing the background and objectives of the trial Standard antimalarial drugs have become largely ineffective in many malaria endemic regions, except for the artemisinin-based combination therapies (ACTs) such artemether-lumefantrine, current standard-of-care for P. falciparum malaria. Partial artemisinin combination tolerance has already emerged in South East Asia, thereby posing a grave threat to global malaria control and elimination programs. Validated and candidate Pfkelch13 mutations are used as artemisinin resistance markers, and several of these mutations were recently reported in Africa. The rising number of Pfkelch13 mutations is alarming, as it can be a prelude to the development of resistance to artemisinins in Africa. There is an urgent medical need for innovative chemical entities with a new mode of action and developed as combinations of drugs with distinct mechanisms of action for synergistic or additive efficacy to mitigate the development of resistance and ensure cure. Additionally, once-daily treatments can improve treatment success and reduce the probability of developing resistance via improved adherence and they could thus accelerate malaria eradication. This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for 3 days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), and or any study treatment-related SAE (Serious Adverse Event) previously.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KALUMA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/07/2023
Actual trial start date 07/03/2024
Anticipated date of last follow up 06/11/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1500
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
2022 002675 10 EudraCT
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group KLU156 400/480mg; 300/360mg; 200/240mg; 100/120mg QD 3 days ganaplacide/lumefantrine-SDF. Oral use, powder; under fed conditions (light meal) 750
Control Group Coartem 80/480mg; 60/360mg; 40/240mg; 20/120mg; BID 3 days Coartem (artemether-lumefantrine). Oral use, dispersible tablet; under fed conditions (light meal) 750 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Core Phase: 1. Male or female patients ≥ 5 kg of body weight and ≥ 2 months of age 2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/ µL at the time of pre-screening with or without other Plasmodium spp. co-infection. 3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 h (at least documented verbally) 4. Negative pregnancy test for patients of childbearing potential 5. Signed informed consent (pre-screening and screening for the Core phase) must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian (LAR). If the parent/LAR is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parental/LAR consent or as per local ethical standards 6. The patient and/or their parent/LAR is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Extension Phase: 1. Patients randomized into the Core phase and having completed it. 2. Signed informed consent (for the Extension phase) must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/LAR. If the parent/LAR is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines. Core Phase: 1. Signs and symptoms of severe malaria according to WHO 2015 2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19) 3. Severe malnutrition: • For patients ≥ 12 years: body mass index (BMI) < 16.0 • For children < 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC < 115 mm) 4. Repeated vomiting (defined as >3 times in the 24 h prior to start of screening) or severe diarrhea (defined as >3 watery stools in the 24 h prior to start of screening) 5. Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia 6. Anemia (hemoglobin level < 7 g/dL) 7. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., HIV patients on ART therapy or TB patients on treatment), or which may jeopardize the patient in case of participation in the study. 8. Any of the following: • AST/ALT > 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin • Total bilirubin > 3 x ULN • Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening 9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown) 10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease 11. Pregnant or nursing (lactating) patients Extension Phase: Patients meeting the following criteria in the Core phase are not eligible for transition into the Extension phase: • Early Treatment Failure (KLU156 or Coartem treatment arm) • Patients with reported study treatment-related SAE (KLU156 or Coartem). 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Month(s) 999 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/08/2023 CNES Comite National d ethique de la sante
Ethics Committee Address
Street address City Postal code Country
Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu Kinshasa 0000 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Core Phase: To confirm the efficacy of KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection) by demonstrating that KLU156 is non-inferior to Coartem (non‑inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29. Day 29
Secondary Outcome Core Phase: To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29. Day 29
Secondary Outcome Core Phase: To confirm the efficacy of KLU156 by assessing uncorrected and PCR-corrected ACPR at additional time points, as well as fever and parasite clearance times, gametocyte carriage over time between the two treatment arms. Day 1 at 12h, Day 2 at 24h, Day 3 at 48h, Day 4 at 72h and Days 22, 29 and 43
Secondary Outcome Core Phase: To compare the safety and tolerability profile of the two treatment arms on adverse events (AEs), general laboratory, vital signs and ECG measurements. All study timepoints
Secondary Outcome Extension Phase: To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection) for a maximum of 2 years. All study timepoints
Secondary Outcome Extension Phase: To evaluate efficacy over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection) for a maximum of 2 years. Day 29
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
INSTech Bobo Dioulasso Bobo Dioulasso Burkina Faso
URCH Main Centre URCN Nanoro Nanoro Burkina Faso
Centre Medical avec antenne ch Saint Maximilien Kolbe District Sabou Sabou Burkina Faso
Hopital Regional Institut Pierre Richet Centre Agboville Agboville Cote Divoire
Ayame General Hospital Ayame Ayame Cote Divoire
Formation Sanitaire Communautaire d Anonkoua Koute Pasteur Institute of Ivory Coast Abidjan Abidjan Cote Divoire
Centre de Sante Urbain d Azaguie Agboville Agboville Cote Divoire
HGR IME Kimpese Kimpese Kimpese Democratic Republic of the Congo
HGR Kenge Kenge Kenge Democratic Republic of the Congo
HGR Kisantu Kisantu Kisantu Democratic Republic of the Congo
HGR Masimanimba Masimanimba Masimanimba Democratic Republic of the Congo
CHREM Libreville Libreville Gabon
Centre de Recherches Medicales Lambarene Lambarene Gabon
Malaria Research Center Agogo Agogo Ghana
Kintampo Health Research Centre Kintampo Kintampo Ghana
Navrongo Health Research Centre Navrongo Navrongo Ghana
KEMRI Research Center Siaya Referral Hospital Kisumu Kisumu Kenya
KEMRI Kombewa Main Centre Kombewa Clinical Research Centre Walter Reed Project Kombewa Kombewa Kenya
Creates Research Centre Strathmore University Ahero Ahero Kenya
Malaria Research and Training Center Sikasso Sikasso Mali
ISM Manhica Manhica Mozambique
CSI Niamey Niamey Niger
Center for Malaria University of Ilorin Ilorin Ilorin Nigeria
Rinda Ubuzima CMHS KG Kigali Kigali Rwanda
CFHR Gisenyi Hospital Rubavu Rubavu Rwanda
CFHR Gihundwe Hospital Rusizi Rusizi Rwanda
Gatenga Health Centre Kigali Kigali Rwanda
Rukoma Health Center Sake Sector Rukoma Cell Sangano Village Sake Sake Rwanda
NIMR Korogwe Korogwe Korogwe Tanzania
National Inst for Medical Research Tanga Tanga Tanzania
Ifakara Health Research Institute Ifakara Health Research Institute Bagamoyo Bagamoyo Tanzania
Infectious Diseases Research Collaboration Tororo Tororo Uganda
Tropical Diseases Research Centre Ndola Ndola Zambia
St Pauls Mission Hospital Nchelenge Nchelenge Zambia
Centre Medical Urbain de Banfora Banfora Banfora Burkina Faso
Training Research Unit Excellence Blantyre Blantyre Malawi
Rwesero Health Center Rwesero Rwesero Rwanda
Hopital General De Ref De Kenya Lubumbashi Lubumbashi Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Medicines for Malaria Venture 20 Route de Pre Bois Geneva Switzerland
Novartis Pharma AG Fabrikstrasse 2 Basel CH-4056 Switzerland
European and Developing Countries Clinical Trials Partnership PO Box 93015 The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Novartis Pharma AG Fabrikstrasse 2 Basel CH-4056 Switzerland Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Medicines for Malaria Venture 20 Route de Pre Bois Geneva Switzerland
WANECAM 2 Consortium MRTC, FMOS-FAPH, Point G Bamako BP 1805 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Novartis Pharma AG Novartis Pharma AG novartis.email@novartis.com +41613241111 Fabrikstrasse 2
City Postal code Country Position/Affiliation
Basel CH-4056 Switzerland Trial Director
Role Name Email Phone Street address
Scientific Enquiries Novartis Pharma AG Novartis Pharma AG novartis.email@novartis.com +41613241111 Fabrikstrasse 2
City Postal code Country Position/Affiliation
Basel CH-4056 Switzerland Trial Director
Role Name Email Phone Street address
Principal Investigator TBD TBD TBD@TBD.com 123456789 TBD
City Postal code Country Position/Affiliation
TBD Mali TBD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com. Study Protocol This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial line with applicable laws and regulations
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 20/02/2023 Brief background of the study was requested after initial submission for review This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase. Standard antimalarial drugs have become largely ineffective in many malaria endemic regions, except for the artemisinin-based combination therapies (ACTs) such artemether-lumefantrine, current standard-of-care for P. falciparum malaria. Partial artemisinin combination tolerance has already emerged in South East Asia, thereby posing a grave threat to global malaria control and elimination programs. Validated and candidate Pfkelch13 mutations are used as artemisinin resistance markers, and several of these mutations were recently reported in Africa. The rising number of Pfkelch13 mutations is alarming, as it can be a prelude to the development of resistance to artemisinins in Africa. There is an urgent medical need for innovative chemical entities with a new mode of action and developed as combinations of drugs with distinct mechanisms of action for synergistic or additive efficacy to mitigate the development of resistance and ensure cure. Additionally, once-daily treatments can improve treatment success and reduce the probability of developing resistance via improved adherence and they could thus accelerate malaria eradication. This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for 3 days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), and or any study treatment-related SAE (Serious Adverse Event) previously.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 03/06/2024 Update 07 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 03/06/2024 Update Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons INSTech, 540 Avenue de Sya, Bobo Dioulasso, , Burkina Faso INSTech, Bobo Dioulasso, Bobo Dioulasso, , Burkina Faso
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons URCH Main Centre URCN, St Camille de Nanoro, Nanoro, , Burkina Faso URCH Main Centre URCN, Nanoro, Nanoro, , Burkina Faso
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Centre Medical avec antenne ch Saint Maximilien Kolbe District, Sanitaire de Sabou Region Sanitaire de Centre Ouest, Sabou, , Burkina Faso Centre Medical avec antenne ch Saint Maximilien Kolbe District, Sabou, Sabou, , Burkina Faso
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Hopital Regional Institut Pierre Richet Centre, Hospitalier Regional d Agboville Institut National de Sante , Agboville, BP 154, Cote Divoire Hopital Regional Institut Pierre Richet Centre, Agboville, Agboville, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Ayame General Hospital, Pasteur Inst of Ivory Coast, Ayame, PO Box 81, Cote Divoire Ayame General Hospital, Ayame, Ayame, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Formation Sanitaire Communautaire d Anonkoua Koute Pasteur Institute of Ivory Coast, Abidjan 01, Abidjan , BP 490, Cote Divoire Formation Sanitaire Communautaire d Anonkoua Koute Pasteur Institute of Ivory Coast, Abidjan, Abidjan , , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Centre de Sante Urbain d Azaguie, Agboville Ivory Coast, Agboville, BP 154, Cote Divoire Centre de Sante Urbain d Azaguie, Agboville, Agboville, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons CHREM, RNI 8929, Libreville, , Gabon CHREM, Libreville, Libreville, , Gabon
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Centre de Recherches Medicales, Centre de Recherches Medicales, Lambarene, BP 242, Gabon Centre de Recherches Medicales, Lambarene, Lambarene, , Gabon
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Malaria Research Center, Agogo Presbyterian Hospital, Agogo, PO Box 27, Ghana Malaria Research Center, Agogo, Agogo, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Kintampo Health Research Centre , Mistry of Health No. 2 Health loop, Kintampo North Muncipality, Brong Ahafo Region, Kintampo, , Ghana Kintampo Health Research Centre , Kintampo, Kintampo, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Navrongo Health Research Centre, Behind Navrongo War Memorial Hospital Navrongo Hospital Road, Navrongo, PO Box114, Ghana Navrongo Health Research Centre, Navrongo, Navrongo, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons KEMRI Research Center Siaya Referral Hospital, Off Kisumu Busia Road, Siaya, Kisumu, , Kenya KEMRI Research Center Siaya Referral Hospital, Kisumu, Kisumu, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons KEMRI Kombewa Main Centre Kombewa Clinical Research Centre Walter Reed Project, Off Kisumu Bondo Road Opposite Kombewa Sub-county Hospital Kombewa, Kombewa, , Kenya KEMRI Kombewa Main Centre Kombewa Clinical Research Centre Walter Reed Project, Kombewa, Kombewa, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Creates Research Centre Strathmore University, Madraka Estate Ole Sangale Road, Ahero, 00200, Kenya Creates Research Centre Strathmore University, Ahero, Ahero, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Malaria Research and Training Center, Centre de Sante de Bougoula-Ha Sikasso Region, Sikasso, BP 1805, Mali Malaria Research and Training Center, Sikasso, Sikasso, , Mali
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons ISM, Rua 12 Bairro Cambeve , Manhica, CP 1929, Mozambique ISM, Manhica, Manhica, , Mozambique
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons CSI, CSI de Foulan Koira, Koira Tegui District , Niamey, , Niger CSI, Niamey , Niamey, , Niger
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Rinda Ubuzima CMHS KG, 11 Avenue, 47 Remera Campus, Kigali, BP 4560, Rwanda Rinda Ubuzima CMHS KG, Kigali, Kigali, , Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons CFHR Gisenyi Hospital, Rue de l Hopital Gisenyi Road, Rubavu, , Rwanda CFHR Gisenyi Hospital, Rubavu, Rubavu, , Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons CFHR Gihundwe Hospital, Kamembe Sector RN6 3b Western Province Rusizi, Rusizi, , Rwanda CFHR Gihundwe Hospital, Rusizi, Rusizi, , Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Gatenga Health Centre, Kicukiro District Gatenga Sector Karambo Cell Ruhuka Village Ave239R VH9 0000, Kigali, , Rwanda Gatenga Health Centre, Kigali, Kigali, , Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Rukoma Health Center Sake Sector Rukoma Cell Sangano Village, East Province Ngoma District, Sake, , Rwanda Rukoma Health Center Sake Sector Rukoma Cell Sangano Village, Sake, Sake, , Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons NIMR Korogwe, Magunga Hospital Road, , Korogwe, , Tanzania NIMR Korogwe, Korogwe, Korogwe, , Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons National Inst for Medical Research, NIMR Hospital Street , Tanga, 5004, Tanzania National Inst for Medical Research, Tanga, Tanga, , Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Ifakara Health Research Institute Ifakara Health Research Institute, District hospital 53, Bagamoyo, , Tanzania Ifakara Health Research Institute Ifakara Health Research Institute, Bagamoyo, Bagamoyo, , Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Infectious Diseases Research Collaboration, Main Centre Tororo Hospital Station Road, Tororo, 10102, Uganda Infectious Diseases Research Collaboration, Tororo, Tororo, , Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons Tropical Diseases Research Centre, Ndola Teaching Hospital 6th and 7th Floor, Ndola, , Zambia Tropical Diseases Research Centre, Ndola, Ndola, , Zambia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/06/2024 Data privacy reasons St Pauls Mission Hospital, Mununga Kashikishi Road, Nchelenge, , Zambia St Pauls Mission Hospital, Nchelenge, Nchelenge, , Zambia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 27/02/2025 new centre Centre Medical Urbain de Banfora, Banfora, Banfora, , Burkina Faso
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 27/02/2025 new centre Training Research Unit Excellence, Blantyre , Blantyre , , Malawi
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 27/02/2025 new centre Rwesero Health Center, Rwesero, Rwesero, , Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 27/02/2025 new centre Hopital General De Ref De Kenya, Lubumbashi, Lubumbashi, , Congo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 27/02/2025 new centre Hopital General De Ref De Kenya, Lubumbashi, Lubumbashi, , Congo Hopital General De Ref De Kenya, Lubumbashi, Lubumbashi, , Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/02/2023 Change requested due to inability to identify ethics committee however no updates made as the name and address of the committee is taken from the footer of an official letter; it is based on an approval letter for a running study FALSE, Comite National d ethique de la sante, Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr, FALSE, Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/02/2023 Change requested due to inability to identify committee however no changes have been made as the name and address is taken from the footer of an official letter; the name and address is based on an approval letter for a running study. Please note the name of the ethics committee is CNES (Comite National d ethique de la sante) FALSE, Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr, FALSE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/02/2023 Change requested due to inability to identify committee however no changes have been made as the name and address is taken from the footer of an official letter; the name and address is based on an approval letter for a running study. Please note the name of the ethics committee is CNES (Comite National d ethique de la sante) FALSE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr, FALSE, Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/02/2023 Change requested due to inability to identify committee however no changes have been made as the name and address is taken from the footer of an official letter; the name and address is based on an approval letter for a running study. Please note the name of the ethics committee is CNES (Comite National d ethique de la sante) FALSE, Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr, FALSE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/03/2023 Date changed due to a slight delay. Have not added planned dates for ethics approval for other sites we are planning to conduct our study in as an exhaustive list was not made available for our other already approved studies registered in PACTR FALSE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 28 Feb 2023, , +243998419816, feli1munday@yahoo.fr, FALSE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 10 Mar 2023, , +243998419816, feli1munday@yahoo.fr,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/06/2024 Update FALSE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 10 Mar 2023, , +243998419816, feli1munday@yahoo.fr, TRUE, CNES Comite National d ethique de la sante , Immeuble PNMLS, 1er Niveau, Local 5, Commune de Kasa-Vubu, Kinshasa, 0000, Democratic Republic of the Congo, 10 Mar 2023, 09 Aug 2023, +243998419816, feli1munday@yahoo.fr,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Issaka , Sagara, Dr., isagara@icermali.org, , +22376459079, MRTC, FMOS-FAPH, Point G, Bamako, BP 1805, Mali, University of Sciences Techniques and Technologies Bamako Principal Investigator, TBD, TBD, Dr., tbd@tbd.com, , 123456789, TBD, TBD, , Mali, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., tbd@tbd.com, , 123456789, TBD, TBD, , Mali, TBD Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Mali, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Jean, Ouedraogo, Prof., jbouedraogo@gmail.com, , +22620970811, 540 Avenue de Sya, Bobo Dioulasso, , Burkina Faso, INSTech
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Jean, Ouedraogo, Prof., jbouedraogo@gmail.com, , +22620970811, 540 Avenue de Sya, Bobo Dioulasso, , Burkina Faso, INSTech Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Burkina Faso, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Burkina Faso, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Berenger, Kabore, Dr., kaboreberenger@gmail.com, , +22650330881, St Camille de Nanoro, Nanoro, , Burkina Faso, 11 BP 218 CMS 11
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Berenger, Kabore, Dr., kaboreberenger@gmail.com, , +22650330881, St Camille de Nanoro, Nanoro, , Burkina Faso, 11 BP 218 CMS 11
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Jean, Kabore, Dr., m.kabore@gras.bf, , +22625355690, Sanitaire de Sabou Region Sanitaire de Centre Ouest, Sabou, , Burkina Faso, Centre Medical avec antenne ch Saint Maximilien Kolbe District
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Jean, Kabore, Dr., m.kabore@gras.bf, , +22625355690, Sanitaire de Sabou Region Sanitaire de Centre Ouest, Sabou, , Burkina Faso, Centre Medical avec
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Koudou, Guibehi, Prof., guibehi.koudou@csrs.ci, , +22540499946, Hospitalier Regional d Agboville Institut National de Sante, Agboville, BP 154, Cote Divoire, Hopital Regionale Institut Pierre Richet Centre
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Koudou, Guibehi, Prof., guibehi.koudou@csrs.ci, , +22540499946, Hospitalier Regional d Agboville Institut National de Sante, Agboville, BP 154, Cote Divoire, Hopital Regionale Institut Pierre Richet Centre Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Cote Divoire, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Cote Divoire, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Andre, Offianan, Dr., andre_offianan@yahoo.fr, , +22521304321, Pasteur Inst of Ivory Coast, Ayame, PO Box 81, Cote Divoire, Ayame General Hospital
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Andre, Offianan, Dr., andre_offianan@yahoo.fr, , +22521304321, Pasteur Inst of Ivory Coast, Ayame, PO Box 81, Cote Divoire, Ayame General Hospit
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Andre, Offianan, Dr., andre_offianan@yahoo.fr, , +22521304321, Abidjan 01, Abidjan, BP 490, Cote Divoire, Formation Sanitaire Communautaire d Anonkoua Koute Pasteur Institute of Ivory Coast
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Andre, Offianan, Dr., andre_offianan@yahoo.fr, , +22521304321, Abidjan 01, Abidjan, BP 490, Cote Divoire, Formation Sanitaire
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Serge Brice , Assi, Dr., assisergi@yahoo.fr, , +225014049994, Agboville Ivory Coast, Agboville, BP 154, Cote Divoire, Centre de Sante Urbain d Azaguie
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Serge Brice , Assi, Dr., assisergi@yahoo.fr, , +225014049994, Agboville Ivory Coast, Agboville, BP 154, Cote Divoire, Centre de Sante Urba
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Rella, Manego, Dr., manegorella@yahoo.fr, , +24107155748, RNI 8929, Libreville, , Gabon, CHREM
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Rella, Manego, Dr., manegorella@yahoo.fr, , +24107155748, RNI 8929, Libreville, , Gabon, CHREM Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Gabon, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Gabon, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Rella, Manego, Dr., manegorella@yahoo.fr, , +24107989191, Centre de Recherches Medicales, Lambarene, BP 242, Gabon, Centre de Recherches Medicales
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Rella, Manego, Dr., manegorella@yahoo.fr, , +24107989191, Centre de Recherches Medicales, Lambarene, BP 242, Gabon, Centre de Recherches
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Tsiri, Agbenyega, Prof., tsiri@ghana.com, , +233208113848, Agogo Presbyterian Hospital, Agogo, PO Box 27, Ghana, Malaria Research Center
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Tsiri, Agbenyega, Prof., tsiri@ghana.com, , +233208113848, Agogo Presbyterian Hospital, Agogo, PO Box 27, Ghana, Malaria Research Center Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Ghana, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Ghana, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Kwaku, Asante, Dr., kwakupoku.asante@kintampo-hrc.org, , +23303520920378, Mistry of Health No. 2 Health loop, Kintampo North Muncipality, Brong Ahafo Region, Kintampo, , Ghana, Kintampo Health Research Centre
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Kwaku, Asante, Dr., kwakupoku.asante@kintampo-hrc.org, , +23303520920378, Mistry of Health No. 2 Health loop, Kintampo North Muncipality, Brong Ahafo Region, Kintampo, , Ghana, Kintampo Health Rese
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Patrick, Odum Ansah, Dr., patrick.ansah@navrongo-hrc.org, , +233382122310, Behind Navrongo War Memorial Hospital Navrongo Hospital Road, Kintampo, , Ghana, Navrongo Health Research Centre
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Patrick, Odum Ansah, Dr., patrick.ansah@navrongo-hrc.org, , +233382122310, Behind Navrongo War Memorial Hospital Navrongo Hospital Road, Kintampo, , Ghana, Navrongo Health Rese
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Patricia, Achieng Ojwang, Dr., pattojey@gmail.com, , +254725389246, Off Kisumu Busia Road, Siaya, Kisumu, , Kenya, KEMRI Research Center Siaya Referral Hospital
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Patricia, Achieng Ojwang, Dr., pattojey@gmail.com, , +254725389246, Off Kisumu Busia Road, Siaya, Kisumu, , Kenya, KEMRI Research Center Siaya Referral Hospital Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Kenya, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Kenya, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Bernhard, Ogutu, Dr., bernhards.ogutu@usamru-k.org, , +254733966065, Off Kisumu Bondo Road Opposite Kombewa Sub-county Hospital Kombewa, Kombewa, , Kenya, KEMRI Kombewa Main Centre Kombewa Clinical Research Centre Walter Reed Project
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Bernhard, Ogutu, Dr., bernhards.ogutu@usamru-k.org, , +254733966065, Off Kisumu Bondo Road Opposite Kombewa Sub-county Hospital Kombewa, Kombewa, , Kenya, KEMRI Kombewa Main C
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Bernhard, Ogutu, Dr., bernhards.ogutu@usamru-k.org, , +254703034363, Madraka Estate Ole Sangale Road, Ahero, 00200, Kenya, Creates Research Centre Strathmore University
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Bernhard, Ogutu, Dr., bernhards.ogutu@usamru-k.org, , +254703034363, Madraka Estate Ole Sangale Road, Ahero, 00200, Kenya, Creates Research Cen
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Bakary, Fofana, Dr., bfofana@icermali.org, , +22366789450, Centre de Sante de Bougoula-Ha Sikasso Region, Sikasso, BP 1805, Mali, Malaria Research and Training Center
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Bakary, Fofana, Dr., bfofana@icermali.org, , +22366789450, Centre de Sante de Bougoula-Ha Sikasso Region, Sikasso, BP 1805, Mali, Malaria Research and
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Bassat, Quique, Dr., quique.bassat@isglobal.org, , +34609556300, Rua 12 Bairro Cambeve , Manhica, CP 1929, Mozambique, ISM
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Bassat, Quique, Dr., quique.bassat@isglobal.org, , +34609556300, Rua 12 Bairro Cambeve , Manhica, CP 1929, Mozambique, ISM Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Mozambique, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Mozambique, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Eric, Adehossi, Prof., eadehossi@yahoo.fr, , +22796972114, CSI de Foulan Koira, Koira Tegui District , Niamey, , Niger, CSI
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Eric, Adehossi, Prof., eadehossi@yahoo.fr, , +22796972114, CSI de Foulan Koira, Koira Tegui District , Niamey, , Niger, CSI Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Niger, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Niger, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Olugbenga, Mokuolu, Prof., oamokuolu@yahoo.com, , +2348037137407, Ilorin, Ilorin, , Nigeria, Center for Malaria University of Ilorin
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Olugbenga, Mokuolu, Prof., oamokuolu@yahoo.com, , +2348037137407, Ilorin, Ilorin, , Nigeria, Center for Malaria University of Ilorin Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Nigeria, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Nigeria, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Aline, Uwimana, Dr., aline.uwimana2015@gmail.com, , +250788302073, 11 Avenue, 47 Remera Campus, Kigali, BP 4560, Rwanda, Rinda Ubuzima CMHS KG
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Aline, Uwimana, Dr., aline.uwimana2015@gmail.com, , +250788302073, 11 Avenue, 47 Remera Campus, Kigali, BP 4560, Rwanda, Rinda Ubuzima CMHS KG Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Rwanda, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Rwanda, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Etienne, Karita, Dr., Ekarita@rzhrg-mail.org, , +250788307245, Rue de l Hopital Gisenyi Road, Rubavu, , Rwanda, CFHR Gisenyi Hospital
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Etienne, Karita, Dr., Ekarita@rzhrg-mail.org, , +250788307245, Rue de l Hopital Gisenyi Road, Rubavu, , Rwanda, CFHR Gisenyi Hospita
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Etienne, Karita, Dr., Ekarita@rzhrg-mail.org, , +250788307245, Kamembe Sector RN6 3b Western Province, Rusizi, , Rwanda, CFHR Gihundwe Hospital
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Etienne, Karita, Dr., Ekarita@rzhrg-mail.org, , +250788307245, Kamembe Sector RN6 3b Western Province, Rusizi, , Rwanda, CFHR Gihundwe Hospit
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Jean Claude, Sumanyi, Dr., jcsumanyi@gmail.com, , +25078852010, Kicukiro District Gatenga Sector Karambo Cell Ruhuka Village Ave 239R VH9 0000, Kigali, , Rwanda, Gatenga Health Centre
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Jean Claude, Sumanyi, Dr., jcsumanyi@gmail.com, , +25078852010, Kicukiro District Gatenga Sector Karambo Cell Ruhuka Village Ave 239R VH9 0000, Kigali, , Rwanda, Gatenga Health Centr
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Muco, Mugisha, Dr., mmcjuan92@gmail.com, , +250780147365, East Province Ngoma District, Sake, , Rwanda, Rukoma Health Center Sake Sector Rukoma Cell Sangano Village
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Muco, Mugisha, Dr., mmcjuan92@gmail.com, , +250780147365, East Province Ngoma District, Sake, , Rwanda, Rukoma Health Center
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Samwel, Gesase, Dr., sgesase@yahoo.com, , +243810156911, Magunga Hospital Road, Korogwe, , Tanzania, NIMR Korogwe
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Samwel, Gesase, Dr., sgesase@yahoo.com, , +243810156911, Magunga Hospital Road, Korogwe, , Tanzania, NIMR Korogwe Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Tanzania, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Tanzania, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Geofrey, Makenga, Dr., geofmacky@gmail.com, , +255743802720, NIMR Hospital Street, Tanga, 5004, Tanzania, National Inst for Medical Research
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Geofrey, Makenga, Dr., geofmacky@gmail.com, , +255743802720, NIMR Hospital Street, Tanga, 5004, Tanzania, National Inst for Me
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Ally, Olotu, Dr., aolotu@ihi.or.tz, , +255718927104, District hospital 53, Bagamoyo , , Tanzania, Ifakara Health Research Institute Ifakara Health Research Institute
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Ally, Olotu, Dr., aolotu@ihi.or.tz, , +255718927104, District hospital 53, Bagamoyo , , Tanzania, Ifakara Health Resea
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Adoke, Yeka, Dr., yadoke@yahoo.com, , +256772473533, Main Centre Tororo Hospital Station Road, Tororo, 10102, Uganda, Infectious Diseases Research Collaboration
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Adoke, Yeka, Dr., yadoke@yahoo.com, , +256772473533, Main Centre Tororo Hospital Station Road, Tororo, 10102, Uganda, Infectious Diseases Research Collaboration Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Uganda, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Uganda, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Sebastian, Hachizovu, Dr., sebastianhachizovu4@gmail.com, , +260974223643, Mununga Kashikishi Road, Nchelenge, , Zambia, St Pauls Mission Hospital
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Sebastian, Hachizovu, Dr., sebastianhachizovu4@gmail.com, , +260974223643, Mununga Kashikishi Road, Nchelenge, , Zambia, St Pauls Mission Hospital Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Zambia, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Zambia, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Christine, Manyando, Dr., cmanyando@yahoo.com, , +260977771763, Ndola Teaching Hospital 6th and 7th Floor, Ndola, , Zambia, Tropical Diseases Research Centre
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Christine, Manyando, Dr., cmanyando@yahoo.com, , +260977771763, Ndola Teaching Hospital 6th and 7th Floor, Ndola, , Zambia, Tropical Diseases Re
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Ntontolo, Patrick, Dr., patrickntontolo@yahoo.fr, , +243898603834, Kimpese, Kimpese, , Democratic Republic of the Congo, HGR IME Kimpese
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Ntontolo, Patrick, Dr., patrickntontolo@yahoo.fr, , +243898603834, Kimpese, Kimpese, , Democratic Republic of the Congo, HGR IME Kimpese Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Democratic Republic of the Congo, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, TBD, TBD, Dr., TBD@TBD.com, , 123456789, TBD, TBD, , Democratic Republic of the Congo, TBD
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Lydie, Kutakani Mfutila, Dr., lydiekutakani6@gmail.com, , +243828590290, Kenge, Kenge, , Democratic Republic of the Congo, HGR Kenge
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Lydie, Kutakani Mfutila, Dr., lydiekutakani6@gmail.com, , +243828590290, Kenge, Kenge, , Democratic Republic of the Congo, HGR Kenge
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Miesi, Kimbondo, Dr., nakims1942@gmail.com, , +243899213724, Kisantu, Kisantu, , Democratic Republic of the Congo, HGR Kisantu
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Miesi, Kimbondo, Dr., nakims1942@gmail.com, , +243899213724, Kisantu, Kisantu, , Democratic Republic of the Congo, HGR Kisantu
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 03/03/2023 Additional information for other sites planned for recruitment as requested Principal Investigator, Joseph, Makasa, Dr., josephmakasa68@gmail.com, , +243817763893, Masimanimba, Masimanimba, , Democratic Republic of the Congo, HGR Masimanimba
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/06/2024 Data privacy reasons Principal Investigator, Joseph, Makasa, Dr., josephmakasa68@gmail.com, , +243817763893, Masimanimba, Masimanimba, , Democratic Republic of the Congo, HGR Masimanimba
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 21/02/2023 IPD Sharing statement as defined by WHO requested Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies The investigator will receive a summary of the study results in plain language. They can share these results with patients once the core and extension phases have been completed. About a year after the study is completed, a summary of the results, will be publicly available at novctrd.com. The study results will also be made publicly available at ClinicalTrials.gov, or at eudract.ema.europa.eu, and at pactr.samrc.ac.za. These websites can be searched using the study code CKLU156A12301 or its name, KALUMA.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 03/03/2023 As requested, amending in line with the IPD sharing statement as defined by WHO The investigator will receive a summary of the study results in plain language. They can share these results with patients once the core and extension phases have been completed. About a year after the study is completed, a summary of the results, will be publicly available at novctrd.com. The study results will also be made publicly available at ClinicalTrials.gov, or at eudract.ema.europa.eu, and at pactr.samrc.ac.za. These websites can be searched using the study code CKLU156A12301 or its name, KALUMA. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.