Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

Phase 3

• Conditions: Uncomplicated Malaria

• Registration Number: NCT00406146
• Lead Sponsor: University of Ghana Medical School

Brief Summary

Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Status Verified: 2006-11
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-30
• Last Update Submitted: 2006-11-30
• Study Completion: 2006-12
• Study First Posted: 2006-12-04
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• microscopically confirmed acute uncomplicated falciparum malaria;
• temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
• willingness to comply with follow up schedule;
• written informed consent by accompanying parent or guardian

Exclusion Criteria

• features of severe malaria or danger signs of malaria
• known intolerance or allergy to any of the study medications
• known treatment with any of the study medications in the month preceding enrollment
• serious underlying disease that may mask outcome assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Korle Bu Teaching Hospital; 🇬🇭 Accra, Ghana