Adherence to Lumefantrine-Artemether

Centers for Disease Control and Prevention300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Malaria, Uncomplicated

Interventions

artemether-lumefantrineDRUG

Eligibility

Sex: ALLMin age: 0 YearsMax age: 59 Months

Medical Language ↔ Plain English

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.

Locations (1)

Mkuranga District Hospital

Mkwanga, Mkuranga District, Tanzania

Data from ClinicalTrials.gov

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