Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2004
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedDecember 4, 2006
November 1, 2006
November 13, 2006
November 30, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ghana Medical Schoollead
- University of Copenhagencollaborator
Study Sites (1)
Korle Bu Teaching Hospital
Accra, Ghana
Related Publications (1)
Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008 Jul 11;7:127. doi: 10.1186/1475-2875-7-127.
PMID: 18620577DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2006
First Posted
December 4, 2006
Study Start
October 1, 2004
Study Completion
December 1, 2006
Last Updated
December 4, 2006
Record last verified: 2006-11