Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Collaborators: Avenue Appia 20; CH - 1211 Geneva 27; Switzerland; World Health Organization
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

Inclusion Criteria:

• male or female weighing ≥ 5kg and ≤ 25kg

• P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3

• with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite

Exclusion Criteria:

• complicated malaria

• ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks

• severe anaemia

• severe malnutrition

• malaria due to other than P. falciparum

Other protocol-defined inclusion/exclusion criteria may apply