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

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: AQAS

• Registration Number: NCT00425763
• Lead Sponsor: Centers for Disease Control and Prevention

Brief 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.

Study Timeline

• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-23
• Study Start: 2007-05
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• age 6-59 months
• axillary temperature ≥ 37.5º C, or history of fever in previous 24 hours
• weight ≥ 5.0 kg
• slide-confirmed infection with P. falciparum
• parasitemia 2000-200,000 asexual forms per μl
• ability and willingness to attend stipulated follow-up visits

Exclusion Criteria

• signs or symptoms of severe disease
• weight-for-age ≤ 3rd percentile on Kenya growth charts
• slide confirmed infection with any other Plasmodium spp., besides falciparum
• severe anemia, defined as Hb < 7 g/dl
• known hypersensitivity to any of the drugs being tested
• enrolled in IPTi trial
• known chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AQAS	AQAS	-

Primary Outcome Measures

Name	Time	Method
28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological

Secondary Outcome Measures

Name	Time	Method
Side effects
Molecular markers of drug resistance

Trial Locations

Locations (1)

Bondo District Hospital; 🇰🇪 Kisumu, Kenya