Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
Design: Single-centre
Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the
efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural
and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).
Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary
temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health
centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital
outpatient department.
Sample size: N=120
Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three
days (first and second day: 10mg/kg, third day: 5mg/kg).
Statistical procedures: The primary analysis parameter is the proportion of clinical failures
on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without
PCR correction), the rate of early clinical failures, the rate of late parasitological
failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the
overall group of study children and for rural (n=50) and urban (n=50) study children
separately.
Study duration and dates: The study will be implemented in September-December 2005.
Phase:
Phase 2
Details
Lead Sponsor:
Heidelberg University
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso