Malaria Clinical Trial
Official title:
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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