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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

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.

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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.

Conditions

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Malaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AQAS

Group Type EXPERIMENTAL

AQAS

Intervention Type DRUG

AQAS dosed by body weight, on days 0, 1, 2

Interventions

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AQAS

AQAS dosed by body weight, on days 0, 1, 2

Intervention Type DRUG

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No