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

Uncomplicated Malaria Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00406146
• Other study ID #: 91199 / 104. DAN.8-864
• Secondary ID: GHN-202-M03-M-00
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 13, 2006
• Last updated: November 30, 2006
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: November 2006
• Source: University of Ghana Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: December 2006
• Gender: Both
• Age group: 6 Months to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Uncomplicated Malaria

Intervention

Drug:
• amodiaquine+artesunate/artemether-lumefantrine

Locations

Country	Name	City	State
Ghana	Korle Bu Teaching Hospital	Accra

Sponsors (2)

Lead Sponsor	Collaborator
University of Ghana Medical School	University of Copenhagen

Country where clinical trial is conducted

Ghana,