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
  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:


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
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, see Learn About Clinical Studies.

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 July 22, 2014