Trial | NCT00406146  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    None
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.
Study Started
Oct 31
2004
Study Completion
Dec 31
2006
Last Update
Dec 04
2006
Estimate

Drug amodiaquine+artesunate/artemether-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
No Results Posted