Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
This trial is active, not recruiting.
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
|Principal investigator||George O. Adjei, MD|
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