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

NCT00406146 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-12-04

No results posted yet for this study

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.

Conditions

  • Uncomplicated Malaria

Interventions

DRUG

amodiaquine+artesunate/artemether-lumefantrine

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University of Ghana Medical School

    lead OTHER

Principal Investigators

  • George O. Adjei, MD · Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana

  • Bamenla Q. Goka, MBchB · Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana

  • Jorgen A.L. Kurtzhals, MD, Ph.D · Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2006-12-31

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00406146 on ClinicalTrials.gov