Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo

• Status: Active, not recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. However, reported cases of mutations that confer to Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation of the World Health Organization to conduct regularly test efficacy studies in endemic countries is paramount.

The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.

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

Details

• Lead Sponsor: Ministry of Public Health, Democratic Republic of the Congo
• Collaborators: Centers for Disease Control and Prevention; Global Fund
• 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 a guardian

• living within the study catchment area

• absence of severe manutrition

• absence of infectious diseases that can be responsible of fever

• absence of allergy to the study drugs

Exclusion Criteria:

• presence of general danger signs 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;

• body weight below 5 kg