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

University of Ghana Medical School

Status and phase

Unknown

Phase 3

Conditions

Uncomplicated Malaria

Treatments

Drug: amodiaquine+artesunate/artemether-lumefantrine

Study type

Interventional

Funder types

Other

Identifiers

NCT00406146

91199 / 104. DAN.8-864

GHN-202-M03-M-00

Details and patient eligibility

About

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.

Sex

All

Ages

6 months to 14 years old

Volunteers

No Healthy Volunteers

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