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Completed

NCT Number: NCT00709969

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

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

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Key information

Conditions

Plasmodium Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kemri-Wellcome Trust Programme, Kilifi, Kenya

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemether-lumefantrine

Drug

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

Primary outcomes

  1. Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations

    Time frame: 28 days

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Avenue Appia 20
  • CH - 1211 Geneva 27
  • Switzerland
  • World Health Organization

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Jul 3, 2008
Registry last updated
Jul 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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