Adherence to Lumefantrine-Artemether

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.

Completed

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Key information

Conditions

Malaria, Uncomplicated Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

0 year–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mkuranga District Hospital

Mkwanga, Mkuranga District, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artemether-lumefantrine

Drug

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

Ifakara Health Research and Development Centre

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2006
First posted: Sep 12, 2005
Registry last updated: Sep 12, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed