We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adherence to Lumefantrine-Artemether

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153491
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
Ifakara Health Research and Development Centre
Information provided by:
Centers for Disease Control and Prevention
  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
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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

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 59 Months   (Child)
Sexes Eligible for Study:   All
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
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): NCT00153491


Locations
Tanzania
Mkuranga District Hospital
Mkuranga, Mkuranga District, Tanzania
Sponsors and Collaborators
Centers for Disease Control and Prevention
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:
ClinicalTrials.gov Identifier: NCT00153491     History of Changes
Other Study ID Numbers: CDC-NCID-3602
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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