Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo
TET2020
Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial
1 other identifier
interventional
1,117
1 country
6
Brief Summary
Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs. I In case of increasing failure rates, alternative options can be decided ontime. The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2020
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2020
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2022
CompletedFebruary 9, 2022
February 1, 2022
1.3 years
October 22, 2020
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
PCR adjusted efficacy
absence of fever and negative blood smear during the follow-up until day 28 and new infections occurred during the follow-up.
28 days
Secondary Outcomes (2)
Proportion of adverse events and serious adverse events
28 days
Proportion of participants with positive blood smear at day 3
3 days
Other Outcomes (1)
Presence of Plasmodium falciparum resistance markers and deletion of HRP2
28 days
Study Arms (2)
Artesunate-amodiaquine
EXPERIMENTALTablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days for children weighing 4.5 to 8 kg, and tablets containing 50 mg of artesunate and 135 mg of amodiaquine: one tablet daily for three days for children weighing 9 to 17 kg.
Artemether-lumefantrine
EXPERIMENTALTablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk). One tablet twice daily for children weighing 5 to \<15 kg, two tablets twice daily for those weighing 15 to \<25 kg and three tablets twice daily for those weighing 25 to \< 35 kg, for three days.
Interventions
Artemisinin-based combination treatment
Artemisinin-based combination treatment
Eligibility Criteria
You may qualify if:
- children aged 6 to 59 months
- monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
- axillary temperature ≥ 37.5 °C
- ability to swallow oral medication
- ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule;
- informed consent from a parent or aguardian
- living within the study catchment area
You may not qualify if:
- presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
- body weight \< 5kg
- hemoglobin level \< 5g/ dL or hematocrit \< 15%
- presence of severe malnutrition
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- regular medication, which may interfere with antimalarial pharmacokinetics;
- malaria treatment within 2 days prior to recruitment
- history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Centre Evangélique de Coopération
Kimpese, Bas-Congo Province, Democratic Republic of the Congo
Centre de Santé Lupidi 1
Kapolowe, Haut-Katanga, Democratic Republic of the Congo
Centre de Santé de Référence Mikalayi
Kazumba, Kasai-Central, Democratic Republic of the Congo
Centre de Santé de Référence Rutshuru
Rutshuru, North Kivu, Democratic Republic of the Congo
Centre de Santé Foyer Social
Kisangani, Tshopo, Democratic Republic of the Congo
Centre de Santé Boende 2 Nsele
Boende, Tshuapa, Democratic Republic of the Congo
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gauthier Mesia Kahunu, PhD
University of Kinshasa
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2020
First Posted
November 6, 2020
Study Start
October 26, 2020
Primary Completion
February 8, 2022
Study Completion
February 8, 2022
Last Updated
February 9, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share