Treatment of Uncomplicated Malaria in Benin

Not Applicable

Completed

• Conditions: Uncomplicated Malaria
• Interventions: Drug: artemether-lumefantrine; Drug: amodiaquine-artesunate coformulation; Drug: sulfadoxine-pyrimethamine

• Registration Number: NCT00460369
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief Summary

Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.

The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.

Expected total enrollment: 225 patients

Study start: April 2007; expected completion: December 2007

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-12
• Study First Submitted QC: 2007-04-12
• Study First Posted: 2007-04-13
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-11
• Last Update Posted: 2008-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 6-119 months old
• fever or history of fever of less than 24 hours
• p falciparum parasitemia > 1000 trophozoïtes/µL
• informed consent signed

Exclusion Criteria

• < 5 kg
• danger or severity signs of malaria
• known underlying chronic disease
• Hb < 5g/dL
• adequate malaria treatment taken within 3 days before visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	artemether-lumefantrine	artemether-lumefantrine
3	amodiaquine-artesunate coformulation	amodiaquine-artesunate coformulation
1	sulfadoxine-pyrimethamine	sulfadoxine-pyrimethamine

Primary Outcome Measures

Name	Time	Method
efficacy	day 28

Secondary Outcome Measures

Name	Time	Method
effectiveness comparisons (PCR corrected)	day 14 and day 42
incidence of adverse events	day 42

Trial Locations

Locations (1)

Centre de santé; 🇧🇯 Allada, Benin