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
  Purpose

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.


Condition Intervention Phase
Malaria, Uncomplicated
Drug: artemether-lumefantrine
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Estimated Enrollment: 300
Study Start Date: August 2002
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   up to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153491

Locations
Tanzania
Mkuranga District Hospital
Mkuranga, Mkuranga District, Tanzania
Sponsors and Collaborators
Ifakara Health Research and Development Centre
Investigators
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00153491     History of Changes
Other Study ID Numbers: CDC-NCID-3602
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: United States: Federal Government
Tanzania: National Institute for Medical Research

Keywords provided by Centers for Disease Control and Prevention:
malaria
artemether-lumefantrine
co-artem
Tanzania
adherence

Additional relevant MeSH terms:
Malaria
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 April 17, 2014