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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
Est. primary completion date
Accepts healthy volunteers
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


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, 

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