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Efficacy of Artesunate/Amodiaquine vs Artemether/Lumefantrine for Uncomplicated P. falciparum Malaria in Colombia
NCT04877626Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2008
- Primary completion
- Oct 2009
- Countries
- 1
- Sponsor
- Universidad Nacional de Colombia
- Modality
- Small Molecules
- Conditions
- Plasmodium falciparum malaria
01
Overview
Phase 4, randomised, open-label trial of artesunate + amodiaquine in Plasmodium falciparum malaria (2 arms), sponsored by Universidad Nacional de Colombia. Primary endpoint: Adequate Clinical and Parasitological Response at 28 days. Started Sep 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Artesunate + Amodiaquine
Coarsucam (200mg AQ / 540mg AS) tablets
Artemether + Lumefantrine
Coartem (80mg Artemether / 480mg Lumefantrine) tablets
03
Who it enrols
Adults (>18 years) with uncomplicated P. falciparum malaria (250-100,000 parasites/µl) and fever. Excludes severe malaria, pregnancy, HIV/AIDS, and severe chronic diseases.
04
Endpoints
Primary
Adequate Clinical and Parasitological Response
Secondary
Parasitological Cure (Negative Blood Smears)
Gametocyte Clearance Time
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