Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria
Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria
1 other identifier
interventional
310
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2002
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 2, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedJuly 3, 2008
July 1, 2008
July 2, 2008
July 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations
28 days
Secondary Outcomes (4)
Proportion of patients free of parasites at 7, 14 and at 28 days
Time to clearance from parasites (asexual forms)
Time to clearance of fever
Time to clearance of gametocytes (parasite sexual forms)
Study Arms (1)
1
EXPERIMENTALArtemether-lumefantrine
Interventions
20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- World Health Organizationcollaborator
- Avenue Appia 20collaborator
- CH - 1211 Geneva 27collaborator
- Switzerlandcollaborator
Study Sites (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
Related Publications (1)
Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J. 2008 Nov 27;7:246. doi: 10.1186/1475-2875-7-246.
PMID: 19038036DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 2, 2008
First Posted
July 3, 2008
Study Start
July 1, 2002
Study Completion
February 1, 2003
Last Updated
July 3, 2008
Record last verified: 2008-07