Status:
COMPLETED
Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo
Lead Sponsor:
Ministry of Public Health, Democratic Republic of the Congo
Collaborating Sponsors:
Centers for Disease Control and Prevention
Global Fund
Conditions:
Uncomplicated Plasmodium Falciparum Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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 Afric...
Detailed Description
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in eight malaria sentinel sites around DRC. Children aged 6 to 59 months with confirmed Plasmodium falciparum uncomplicate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
1260 Patients enrolled
Trial Details
Trial ID
NCT06076213
Start Date
May 1 2023
End Date
September 30 2024
Last Update
November 5 2024
Active Locations (7)
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1
Centre de santé de Coopération
Kimpese, Bas-Congo Province, Democratic Republic of the Congo
2
Centre de santé Lupidi 1
Kapolowe, Haut-Katanga, Democratic Republic of the Congo
3
Centres de santé de Mikalayi et Matamba
Kazumba, Kasai-Central, Democratic Republic of the Congo
4
Centre de Santé de Vanga
Vanga, Kwilu, Democratic Republic of the Congo