Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Plasmodium Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709969
• Other study ID #: CCOA566A2403
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2008
• Last updated: July 2, 2008
• Start date: July 2002
• Est. completion date: February 2003

Study information

• Verified date: July 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: The National Agency for Food and Drug Administration and Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: February 2003
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

Drug:
• Artemether-lumefantrine
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

Locations

Country	Name	City	State
Kenya	Kemri-Wellcome Trust Programme	Kilifi
Nigeria	University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training	Ibadan
Tanzania	Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011	Dar es Salaam

Sponsors (5)

Lead Sponsor	Collaborator
Novartis	Avenue Appia 20, CH - 1211 Geneva 27, Switzerland, World Health Organization

Countries where clinical trial is conducted

Kenya,  Nigeria,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations		28 days	No
Secondary	Proportion of patients free of parasites at 7, 14 and at 28 days			No
Secondary	Time to clearance from parasites (asexual forms)			No
Secondary	Time to clearance of fever			Yes
Secondary	Time to clearance of gametocytes (parasite sexual forms)			No