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Adherence to Lumefantrine-Artemether

This study has been completed.
Sponsor:
Collaborator:
Ifakara Health Research and Development Centre
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153491
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 8, 2005
September 8, 2005
August 2002
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No Changes Posted
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Adherence to Lumefantrine-Artemether
Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania

This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.
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Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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Malaria, Uncomplicated
Drug: artemether-lumefantrine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2006
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Inclusion criteria:

  • age < 5 years of age.
  • axillary temperature >= 37.5oC
  • unmixed infection with P. falciparum of between 1,000 and 250,000 asexual parasites/mm3 as determined by microscopic examination of thick, or thick and thin peripheral blood smears.
  • parent/guardian's informed consent and willingness to participate in the study

Exclusion criteria:

  • any evidence of severe or complicated malaria that would require hospitalization for treatment.
  • reported allergy to any antimalarial drugs, including artemisinin derivatives and sulfa drugs.
Both
up to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00153491
CDC-NCID-3602
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Centers for Disease Control and Prevention
Ifakara Health Research and Development Centre
Study Director: Louise Causer, MBBS, MScPH Centers for Disease Control and Prevention
Study Director: Salim Abdulla, MD, PhD Ifakara Health Research and Development Centre
Principal Investigator: Peter B Bloland, DVM, MPVM Centers for Disease Control and Prevention
Study Director: Stephen P Kachur, MD, MPH Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP