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

Novartis

Status and phase: Completed; Phase 3

Conditions: Plasmodium Falciparum Malaria

Treatments: Drug: Artemether-lumefantrine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00709969

CCOA566A2403

Details and patient eligibility

About

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

Enrollment: 310 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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310 participants in 1 patient group

1

Experimental group

Description:

Artemether-lumefantrine

Treatment:

Drug: Artemether-lumefantrine