Status:
COMPLETED
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
Lead Sponsor:
Novartis
Conditions:
Malaria
Falciparum
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
890 Patients enrolled
Trial Details
Trial ID
NCT00386763
Start Date
August 1 2006
End Date
March 1 2007
Last Update
March 12 2009
Active Locations (5)
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1
Novartis
Benin, Benin
2
Novartis
Kenya, Kenya
3
Novartis
Mali, Mali
4
Novartis
Mozambique, Mozambique