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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00709969

Collaborator

World Health Organization (Other), Avenue Appia 20 (Other), CH - 1211 Geneva 27 (Other), Switzerland (Other)

310

Enrollment

Locations

Arm

7.1

Duration (Months)

103.3

Patients Per Site

14.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plasmodium Falciparum Malaria	Drug: Artemether-lumefantrine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

310 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2002

Actual Study Completion Date :

Feb 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Artemether-lumefantrine	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 Other Names: Coartem®, Riamet®, co-artemether

Arm

Intervention/Treatment

Experimental: 1

Artemether-lumefantrine

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

Other Names:

Coartem®, Riamet®, co-artemether

Outcome Measures

Primary Outcome Measures

Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations [28 days]

Secondary Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

male or female weighing ≥ 5kg and ≤ 25kg
1. 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

Contacts and Locations

Locations

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