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Adherence to Lumefantrine-Artemether

Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00153491
Enrollment
300
Registered
2005-09-12
Start date
2002-08-31
Completion date
2006-08-31
Last updated
2005-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Uncomplicated

Keywords

malaria, artemether-lumefantrine, co-artem, Tanzania, adherence

Brief 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.

Interventions

DRUGartemether-lumefantrine

Sponsors

Ifakara Health Research and Development Centre
CollaboratorOTHER
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 59 Months
Healthy volunteers
No

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.

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026