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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Avenue Appia 20
CH - 1211 Geneva 27
Switzerland
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00709969
First received: July 2, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention Phase
Plasmodium Falciparum Malaria
 Drug: Artemether-lumefantrine
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Fever Malaria
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients free of parasites at 7, 14 and at 28 days [ Designated as safety issue: No ]
  • Time to clearance from parasites (asexual forms) [ Designated as safety issue: No ]
  • Time to clearance of fever [ Designated as safety issue: Yes ]
  • Time to clearance of gametocytes (parasite sexual forms) [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: July 2002
Study Completion Date: February 2003
Arms Assigned Interventions
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 Name: Coartem®, Riamet®, co-artemether

  Eligibility

Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709969

Locations
Kenya
Kemri-Wellcome Trust Programme
Kilifi, Kenya
Nigeria
University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training
Ibadan, Nigeria
Tanzania
Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011
Dar es Salaam, Tanzania
Sponsors and Collaborators
Novartis
World Health Organization
Avenue Appia 20
CH - 1211 Geneva 27
Switzerland
Investigators
Study Chair: Novartis Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00709969     History of Changes
Other Study ID Numbers: CCOA566A2403
Study First Received: July 2, 2008
Last Updated: July 2, 2008
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by Novartis:
Malaria
co-artemether
auditory
Plasmodium falciparum
marsh fever
remittent fever
 artemether
artemisinins
lumefantrine
child
infant
Africa

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 22, 2013