Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania (C3)
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The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.
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Layout table for eligibility information
Ages Eligible for Study:
up to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aged <5 years
Weight >5 kg
Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
Having a history of fever in the preceding 24 h
Able to ingest tablets orally
Willing and able to attend stipulated follow-up visits
With written informed consent from parent/guardian for children to participate in the trial.
Presenting with any of the following "danger signs of severe malaria":