Back to resultsAmodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
Primary Purpose
Uncomplicated Malaria
Status
Unknown status
Phase
Phase 3
Locations
Ghana
Study Type
Interventional
Intervention
amodiaquine+artesunate/artemether-lumefantrine
Sponsored by
About this trial
This is an interventional treatment trial for Uncomplicated Malaria
Eligibility 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
Sites / Locations
- Korle Bu Teaching Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00406146
First Posted
November 13, 2006
Last Updated
November 30, 2006
Sponsor
University of Ghana Medical School
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00406146
Brief Title
Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ghana Medical School
Collaborators
University of Copenhagen
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amodiaquine+artesunate/artemether-lumefantrine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George O. Adjei, MD
Organizational Affiliation
Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bamenla Q. Goka, MBchB
Organizational Affiliation
Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorgen A.L. Kurtzhals, MD, Ph.D
Organizational Affiliation
Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korle Bu Teaching Hospital
City
Accra
Country
Ghana
12. IPD Sharing Statement
Citations:
PubMed Identifier
18620577
Citation
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.
Results Reference
derived
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Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
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