Status:
COMPLETED
Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria
Lead Sponsor:
Novartis
Collaborating Sponsors:
World Health Organization
Avenue Appia 20
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00709969
Start Date
July 1 2002
End Date
February 1 2003
Last Update
July 3 2008
Active Locations (3)
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1
Kemri-Wellcome Trust Programme
Kilifi, Kenya
2
University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training
Ibadan, Nigeria
3
Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011
Dar es Salaam, Tanzania