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

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: AQAS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00425763

KEMRI-SSC-1190

CDC-NCID-5022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

AQAS

Experimental group

Treatment:

Drug: AQAS