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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00406146
Enrollment
Unknown
Registered
2006-12-04
Start date
2004-10-31
Completion date
2006-12-31
Last updated
2006-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated Malaria

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.

Interventions

DRUGamodiaquine+artesunate/artemether-lumefantrine

Sponsors

University of Copenhagen
CollaboratorOTHER
University of Ghana Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
6 Months to 14 Years

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

Countries

Ghana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026