Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Novartis

Status and phase

Completed

Phase 3

Conditions

Falciparum

Malaria

Treatments

Drug: Artemether-lumefantrine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386763

CCOA566B2303

Details and patient eligibility

About

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

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

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