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

• Status: Unknown status
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: University of Ghana Medical School
• Collaborator: University of Copenhagen
• Treatments: Amodiaquine; Amodiaquine, artesunate drug combination; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

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