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.: PACTR202405899935406 Date of Approval: 09/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Monitoring chemosensitivity of first-line antimalarial drugs for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 12 years in Burkina Faso
Official scientific title Monitoring chemosensitivity of first-line antimalarial drugs for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 12 years in Burkina Faso
Brief summary describing the background and objectives of the trial 1. Background The potential for artemisinin resistance remains a concern, given the level of susceptibility reported in subsequent studies. It is in this context that the present study aims to evaluate the efficacy and tolerability of AL, DHA-PPQ and PA in the treatment of uncomplicated malaria in children in three health districts in Burkina Faso, namely Banfora, Nanoro and Koupéla. These districts are representative of the epidemiological facies of malaria in Burkina Faso, and are therefore appropriate sites for evaluating the therapeutic efficacy of these antimalarial drugs. This study will provide SP/palu-BF and other partners in the fight against malaria with additional data and evidence of the safety and efficacy of these malaria treatments in Burkina Faso. The study will be a randomized, open-label, three-arm parallel trial with a 1:1:1 allocation. The unit of randomization will be the patient. Participants meeting the inclusion criteria and no defined non-inclusion criteria will be assigned to one of the three treatment arms (i) artéméther-luméfantrine (AL), (ii) dihydro-artémisinine-pipéraquine (DHA-PQ), (iii) pyronaridine-artésunate (PA). Follow-up will be 42 days in all arms, with clinical, parasitological and fingertip blood sampling for genotyping, molecular markers of Plasmodium resistance and pharmacokinetics in the AL arm. 2. Objectives 2.1 Overall objective: To measure the chemosensitivity of first-line antimalarial drugs for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 12 years in Burkina Faso. 2.2 Secondary objectives: - Determine the frequency and nature of adverse events of AL, DHA-PPQ and PA. - Determine Lumefantrine concentration at D7 in the blood of patients in the AL arm. 2.3 Exploratory objectives : - Determine polymorphism of molecular markers of resistance (K13, Pfmdr1, Pfpm2, ...) - Determine HRP2 antigen deletion rate
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/05/2024
Actual trial start date
Anticipated date of last follow up 30/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1386
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Artemether Lumefantrine Artemether-Lumefantrine: 20/120 mg tablet Three (03) days Administer twice daily for 3 days. When the first dose is administered, the second dose should be given 8 hours later (±1 hour). The remaining four doses should be given twice daily (morning and evening). AL should be administered with a fatty food. A minimum of 8 hours must elapse between 2 doses. 462 Active-Treatment of Control Group
Experimental Group Dihydroartemisinin Piperaquine There are two types of tablets : 320/40 mg tablet (320 mg Dihydroartemisinin and 40 mg Dihydroartemisinin ) 160/20 mg tablet (160 mg Dihydroartemisinin and 20 mg Dihydroartemisinin ) Three (03) days Administer once a day for 3 days. As far as possible, use the same administration times each day 462
Experimental Group Aretsunate Pyronaridine There are two types of presentation: a tablet containing 180 mg Pyronaridine tetraphosphate (Pyr) and 60 mg Artesunate (As), and a granulated sachet containing 60 mg Pyronaridine tetraphosphate and 20 mg Artesunate. Three (03) days Administer once a day for 3 days. As far as possible, the same times of day should be observed. 462
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children of both sexes aged 6 months to 12 years inclusive; - Confirmation of P. falciparum mono-infection (parasitaemia between 2000 - 200,000/μl); - Fever (uncorrected body temperature ≥37.5°C or history of fever reported within the last 24 hours). - Hemoglobin level ≥ 5.0 g/dl - Ability to take oral medication; - Parents' ability and willingness to comply with the protocol for the duration of the study and to respect the consultation schedule; - Signature (or thumbprint when parents/guardians are illiterate) of consent form by child's parents or guardians. - Presence of signs of severe malaria according to WHO definitions (appendix 2) - General danger signs in children under five (inability to drink or breastfeed, repeated vomiting (> 2 times in 24 hours), convulsions, unconsciousness, inability to sit or stand) - Body weight less than 5 kg; - Febrile state due to illnesses other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrheal disease with dehydration) or presence of other known chronic or severe underlying diseases or any other condition (e.g. heart, kidney or liver disease, HIV/AIDS) which in the judgment of the clinical investigator would place the subject at potential risk or interfere with the conduct of the study; - History of antimalarial treatment with ACT within the last two weeks; - History of taking any other antimalarial drug within 72 hours prior to the day of the visit; - History of hypersensitivity to any of the drugs tested; - Severe malnutrition (defined by a weight-for-age z-score below -3 or other clinical sign of severe malnutrition); - Known individual or family history of clinical QT interval prolongation or sudden death; - Previous participation in a malaria vaccine clinical trial; - Any other condition which, in the judgment of the investigator, would compromise the safety, rights or well-being of the participant or render him/her unable to comply with the protocol. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 12 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 16/08/2023 Comite Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Ministere de la Sante et de Hygiene publique, 1200 LOGEMENTS Arrondissement 5 secteur 23 Ouagadougou 03 BP7009 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Early Treatment Failure (ETF), Late Treatment Failure (ETF), Adequate Clinical and Parasitological Response (ACPR) and delayed parasite clearance. Day 28 and day 42
Secondary Outcome The incidence of adverse events, The concentration of AL in blood, the prevalence of mutant alleles in resistance genes, the rate of deletions at HRP2 Day 07 for concentration of AL in blood and day 42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut de Recherche en Sciences la Sante Clinical Research Unit of Nanoro BP 18 campus urcn, Nanoro Banfora Koupela Nanoro Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
jhpiego USAID Integrated Health Services Boulevard Ratag Rima Porte 1045 Quartier Gounghin sud Secteur 6 Ouagadougou Burkina Faso
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Secretariat Permanent pour elimination du Paludisme Avenue de la Liberte Ouagadougou Burkina Faso Ministre de la Sante et de Hygiene publique
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Sondo paulsondo@yahoo.fr +22670070184 Campus Nanoro urcn
City Postal code Country Position/Affiliation
Nanoro NA Burkina Faso Researcher at Institut de Recherche en Sciences de la Sante
Role Name Email Phone Street address
Public Enquiries Christian sidzabda Kompaore sidzabda@gmail.com +2260259375 Avenue de la liberte
City Postal code Country Position/Affiliation
Ouagadougou NA Burkina Faso Secretariat Permanent pour elimination du Paludisme
Role Name Email Phone Street address
Scientific Enquiries Halidou Tinto halidoutinto@gmail.com +22670346354 Campus Nanoro
City Postal code Country Position/Affiliation
Nanoro NA Burkina Faso Researcher at Institut de Recherche en Sciences de la Sant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the submitted article, after deidentification (dataset, text, tables, figures, and appendices) Clinical Study Report The principal investigator will submit a report at the end of the study, which will present the key findings at a workshop attended by malaria control partners and Ministry of Health authorities, including SP/Palu coordination. Any amendments to the report will be incorporated into the final report, which will be forwarded to SP/Palu for processing. The results will also be shared with global organizations working in the field of antimalarial resistance such as WHO and WWARN Controlled. The full dataset used to published the report or article
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