Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children 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

PHASE3

Total Enrollment

890 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-03-31

Brief Summary

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This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

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Detailed Description

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Conditions

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Malaria Falciparum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Artemether-lumefantrine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female infants and children ≤12 years of age
* body weight of ≥5 kg and \<35 kg,
* with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion Criteria

* complicated malaria
* persistent vomiting
* malaria due to parasites other than P. falciparum
* antimalarial treatment received in the past 2 weeks
* known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No