Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.
1 other identifier
interventional
890
5 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 12, 2009
March 1, 2009
October 11, 2006
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients free of parasites at day 28.
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Novartis
Benin, Benin
Novartis
Kenya, Kenya
Novartis
Mali, Mali
Novartis
Mozambique, Mozambique
Novartis
Tanzania, Tanzania
Related Publications (2)
Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
PMID: 33289099DERIVEDAbdulla S, Sagara I, Borrmann S, D'Alessandro U, Gonzalez R, Hamel M, Ogutu B, Martensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Bjorkman A, Beck HP, Andriano K, Cousin M, Lefevre G, Ubben D, Premji Z. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet. 2008 Nov 22;372(9652):1819-27. doi: 10.1016/S0140-6736(08)61492-0. Epub 2008 Oct 14.
PMID: 18926569DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 12, 2006
Study Start
August 1, 2006
Study Completion
March 1, 2007
Last Updated
March 12, 2009
Record last verified: 2009-03