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Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00386763
First received: October 11, 2006
Last updated: March 11, 2009
Last verified: March 2009
History of Changes
  Purpose

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.

Resource links provided by NLM:

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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients free of parasites at day 28.

Secondary Outcome Measures:
  • Proportion of patients free of parasites at 7 days and at 14 days
  • Time to clearance from parasites
  • Time to clearance of fever
  • Hematology and biochemistry parameters
  • Electrocardiogram

Estimated Enrollment: 890
Study Start Date: August 2006
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female infants and children ≤12 years of age
  • body weight of ≥5 kg and <35 kg,
  • with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion Criteria:

  • complicated malaria
  • persistent vomiting
  • malaria due to parasites other than P. falciparum
  • antimalarial treatment received in the past 2 weeks
  • known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386763

Locations
Benin
Novartis
Benin, Benin
Kenya
Novartis
Kenya, Kenya
Mali
Novartis
Mali, Mali
Mozambique
Novartis
Mozambique, Mozambique
Tanzania
Novartis
Tanzania, Tanzania
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00386763     History of Changes
Other Study ID Numbers: CCOA566B2303
Study First Received: October 11, 2006
Last Updated: March 11, 2009
Health Authority: Kenya: Ministry of Health

Keywords provided by Novartis:
Marsh fever
Plasmodium infections
Remittent fever
Paludism
Artemether
 Artemisinins
Malaria
Benflumetol
Lumefantrine

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 June 17, 2013