NCT00261222

Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Amodiaquine

Timeline

• Start date: 2005-09-01
• Completion: 2005-11-01
• First posted: 2005-12-02
• Last updated: 2010-02-03

Locations

1 site across 1 country: Burkina Faso