Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Public Health, Democratic Republic of the Congo
• Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo; University of Kinshasa; World Health Organization
• Treatments: Amodiaquine; Artemether; Artemether, Lumefantrine Drug Combination; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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