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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Malaria

Intervention / Treatment
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* Drug: AQAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AQAS<br> | Drug: AQAS<br>* AQAS dosed by body weight, on days 0, 1, 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Molecular markers of drug resistance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, efficacy, intermittent preventive therapy in infants, drug resistance