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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00425763

Acronym

IPTi DRWG

Enrollment

110

Registered

2007-01-23

Start date

2007-05-31

Completion date

2007-08-31

Last updated

2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

malaria, efficacy, intermittent preventive therapy in infants, drug resistance

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.

Interventions

DRUGAQAS

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

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

Design outcomes

Primary

Measure	Time frame
28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological	—

Secondary

Measure	Time frame
Side effects	—
Molecular markers of drug resistance	—

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026