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

Phase 3

Completed

• Conditions: Plasmodium Falciparum Malaria
• Interventions: Drug: Artemether-lumefantrine

• Registration Number: NCT00709969
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study Completion: 2003-02
• Status Verified: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Last Update Submitted: 2008-07-02
• Study First Posted: 2008-07-03
• Last Update Posted: 2008-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Artemether-lumefantrine	Artemether-lumefantrine

Primary Outcome Measures

Name	Time	Method
Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations	28 days

Secondary Outcome Measures

Name	Time	Method
Proportion of patients free of parasites at 7, 14 and at 28 days
Time to clearance of fever
Time to clearance from parasites (asexual forms)
Time to clearance of gametocytes (parasite sexual forms)

Trial Locations

Locations (3)

Kemri-Wellcome Trust Programme; 🇰🇪 Kilifi, Kenya

University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training; 🇳🇬 Ibadan, Nigeria

Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011; 🇹🇿 Dar es Salaam, Tanzania