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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00709969
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : July 3, 2008
World Health Organization
Avenue Appia 20
CH - 1211 Geneva 27
Information provided by:

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
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 : July 2002
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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 Name: Coartem®, Riamet®, co-artemether

Primary Outcome Measures :
  1. Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Proportion of patients free of parasites at 7, 14 and at 28 days
  2. Time to clearance from parasites (asexual forms)
  3. Time to clearance of fever
  4. Time to clearance of gametocytes (parasite sexual forms)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00709969

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
Sponsors and Collaborators
World Health Organization
Avenue Appia 20
CH - 1211 Geneva 27
Study Chair: Novartis Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00709969     History of Changes
Other Study ID Numbers: CCOA566A2403
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: July 2008

Keywords provided by Novartis:
Plasmodium falciparum
marsh fever
remittent fever

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents