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
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: 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
Parasitic Diseases
Protozoan Infections
Artemether
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Coccidiostats
Pharmacologic Actions
Schistosomicides
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014