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

Sponsor

University of Ghana Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT00406146

Collaborator

University of Copenhagen (Other)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Malaria	Drug: amodiaquine+artesunate/artemether-lumefantrine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2004

Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 14 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korle Bu Teaching Hospital	Accra		Ghana

Sponsors and Collaborators

University of Ghana Medical School
University of Copenhagen

Investigators

Principal Investigator: George O. Adjei, MD, Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Principal Investigator: Bamenla Q. Goka, MBchB, Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Principal Investigator: Jorgen A.L. Kurtzhals, MD, Ph.D, Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark