NCT00425763

Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria

Efficacy of Amodiaquine-artesunate in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children at an IPTi Site in Rural Western Kenya

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen.

Detailed description

We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in Kenya. The results will enable us to better interpret the results of the main IPTi trial. We will assess the efficacy of a three day course of amodiaquine plus three days of artesunate (AQ3/AS3) for the treatment of symptomatic, uncomplicated P. falciparum infections. Study subjects are febrile children, 6-59 months old, with laboratory-confirmed uncomplicated P. falciparum infections. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Children will be followed closely for signs of drug failure or recrudescence, and any children failing therapy will be treated with Coartem or, if severe, with quinine. We will also perform drug resistance testing on parasite samples from children with treatment failure. The results of this efficacy trial will allow us to assist policymakers in deciding what drugs should be used for IPTi, should it be adopted into national policy.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	AQAS	AQAS dosed by body weight, on days 0, 1, 2

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2007-01-23
• Last updated: 2012-04-05

Locations

1 site across 1 country: Kenya