Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Phase 3

Completed

• Conditions: Malaria; Falciparum

• Registration Number: NCT00386763
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-12
• Study Completion: 2007-03
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-11
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients free of parasites at day 28.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients free of parasites at 7 days and at 14 days
Time to clearance from parasites
Time to clearance of fever
Hematology and biochemistry parameters
Electrocardiogram

Trial Locations

Locations (1)

Novartis; 🇹🇿 Tanzania, Tanzania

Novartis

🇹🇿Tanzania, Tanzania