This trial is active, not recruiting.

Condition uncomplicated malaria
Treatment amodiaquine+artesunate/artemether-lumefantrine
Phase phase 3
Sponsor University of Ghana Medical School
Collaborator University of Copenhagen
Start date October 2004
End date December 2006
Trial identifier NCT00406146, 91199 / 104. DAN.8-864, GHN-202-M03-M-00


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 6 months up to 14 years old.

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

Additional Information

Principal investigator George O. Adjei, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by University of Ghana Medical School.