ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in 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.
ClinicalTrials.gov Identifier: NCT00386763
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Malaria Falciparum Drug: Artemether-lumefantrine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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.
Study Start Date : August 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Proportion of patients free of parasites at 7 days and at 14 days
  2. Time to clearance from parasites
  3. Time to clearance of fever
  4. Hematology and biochemistry parameters
  5. Electrocardiogram


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:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

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
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics