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.: PACTR202105706263530 Date of Approval: 07/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title In vivo study to monitor the sensitivity of Plasmodium falciparum and other species to Pyronaridineartesunate and Artemether-lumefantrine in Niger.
Official scientific title In vivo study to monitor the sensitivity of Plasmodium falciparum and other species to Pyronaridineartesunate and Artemether-lumefantrine in Niger.
Brief summary describing the background and objectives of the trial Malaria is the leading cause of mortality and morbidity in Niger. According to the statistical yearbooks (from 2011 to 2015), Niger has recorded an annual average of 3,913,006 suspected malaria cases over the past five years. In view of the epidemiological situation, it should be noted that malaria still remains a public health priority in Niger. It represents 27.92% of the disease burden recorded in 2015 [1]. Children under the age of 5 carry around more than half the burden of morbidity (62.43%) and around 3/4 of that of malaria-related mortality in the country (74.65%) of all deaths from malaria in 2014 and 2015 [1]. One of the strategies to fight malaria requires early diagnosis and prompt treatment to reduce mortality. WHO is now advising artemisinin based combination therapy (CTA) in the treatment of simple malaria [2]. Since 2005, Niger has adopted the policy of treatment of clinical cases of malaria by CTA [3]. The therapeutic efficacy of CTAs has been tested in Mali in several clinical trials, some of its studies have shown a rapid selection of resistance markers from partner drugs [4-8]. This could lead to a decrease in effectiveness in the future of these drugs. There are cases of artemisinin resistance on the Thai-Cambodian border indicating the need to monitor the efficacy of ACTs. In Niger, several CTA sensitivity studies were carried out in collaboration with the PNLP. These studies have shown the sensitivity of P. strains
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 14/11/2019
Actual trial start date 14/11/2019
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Active, not 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
Experimental Group Pyramax Body weight No. of Sachets 5 à < 8 kg 1 8 à < 15 kg 2 15 à < 20 kg 3 Number of Tablets 20 à < 24 kg 1 24 à <45 kg 2 45 à < 65 kg 3 ≥65 kg 4 3 days treatment Evaluation of efficay of Pyramax in Niger population 120
Control Group Artemether Lumefantrine Weight Tablet 20/120 mg Tablet 80/480 mg J1 J2 J3 J1 J2 J3 5 à < 15 kg 1 cp x 2 1 cp x 2 1 cp x 2 – – – 15 à < 25 kg 2 cp x 2 2 cp x 2 2 cp x 2 – – – 25 à < 35 kg 3 cp x 2 3 cp x 2 3 cp x 2 – – – ≥ 35 kg 4 cp x 2 4 cp x 2 4 cp x 2 1 cp x 2 1 cp x 2 1 cp x 2 3 Days treatment Efficacy of Artemether Lumefantrine in Niger 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients aged 6 months and over with P. falciparum and / or other species; • Have an axillary temperature greater than or equal to 37.5 ° C or failing this, the onset of a fever in the last 24 hours must be found during questioning. • Parasitaemia must be between 1000 and 200,000 / μL; • Informed consent / assent must be obtained from the patient or, if it is a child, from the person responsible for it after receiving specific information from the protocol Non-inclusion criteria • The presence of one or more general danger signs or any sign of severe or complicated malaria defined by WHO • Refusal to sign or affix his fingerprint on the informed consent; • Any contraindication to any of the molecules in a combination or the presence of a history of allergy; • Pregnancy clinically evident or found on interrogation; • Patients who have received antimalarial treatment for less than 14 days. Study discontinuation criteria for participants • Withdrawal of informed consent; • Protocol violation: Administration of an antimalarial treatment other than Pyr-AS or AL; Intercurrent pathology which may interfere with the classification of the therapeutic response; Detection of an infection by another plasmodial species during monitoring; Incorrect inclusion (non-compliance with inclusion criteria / non-inclusion) Patient lost to follow-up Appearance of a serious adverse event Death or event endangering the participant's survival Event resulting in a significant or lasting incapacity or handicap ... Inability to take treatment Repeated vomiting (≥ two) Absence ≥ 1 follow-up visit during periods taken with AL or Pyr-AS Serious adverse event. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 6 Month(s) 65 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 01/05/2020 Comite National Ethique pour la Recherche en Sante CNERS
Ethics Committee Address
Street address City Postal code Country
Not defined Niamey 0623 Niger
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the sensitivity of Plasmodium falciparum to Pyronaridine-artesunate and Artemether-lumefantrine in Niger Day1, Day2, Day3, Day7, Day14, Day21, Day28, DAy35, Day42
Secondary Outcome • Determine the clinical and parasitological response on D28 after molecular correction by PCR after treatment with Pyr-AS and LA; • To assess the clinical tolerance of Pyr-AS and AL; • Determine the parasite clearance time after treatment with Pyr-AS and AL; • Determine the rate of reinfection within 28 days after treatment with Pyr-AS and AL. J0, J1, J2, J3, J7, J14, J21, J28, J35, J42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CSI Koira Tegui not defined Niger Not Defin Niger
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP WANECAM2 Point G Bamako 1805 Mali
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor European and Developping Countries Clinical Trials partnership EDCTP 2509 AA The Hague The Hague 93015 Netherlands Funding Agency
COLLABORATORS
Name Street address City Postal code Country
INSTech Avenue de Sya Porte 540 Bobo Dioulasso 2779 Burkina Faso
MRTC Point G Bamako 1805 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eric Adehossi eadehossi@yahoo.fr +22790505453 not defined
City Postal code Country Position/Affiliation
Niamey 237/10896 Niger Professeur de Parasitologie Mycologie a UBM de Niamey
Role Name Email Phone Street address
Public Enquiries SANOUSSI SAMUILA s_sanoussi@hotmail.com 0022796290533 not defined
City Postal code Country Position/Affiliation
Niamey 0623 Niger Professeur
Role Name Email Phone Street address
Scientific Enquiries Souleymane Brah brahsouleymane@yahoo.fr +22791516132 Not defined
City Postal code Country Position/Affiliation
Niamey 237/10896 Niger Assistant Universite Abdou MOUMOUNI de Niamey
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will comply with Individual Participant Data (IPD) Sharing Statement as requirement of WHO. The link will be provided as soon as it is developed to give access to data. Results will be published and access available to public will be guaranty. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After final report, the results will be share to public during national and international conferences, meeting and congress. The web link will be provided since developed. http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html Key access criteria will be developed as soon as available.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No URL available yet. 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