Overview

Adherence to Lumefantrine-Artemether

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborator:
Ifakara Health Research and Development Centre
Treatments:
Artemether
Artemether-lumefantrine combination
Artemether, Lumefantrine Drug Combination
Artemisinins
Lumefantrine
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.