Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania

Karolinska University Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Malaria

Interventions

artemether-lumefantrineDRUG

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged \<5 years 2. Weight \>5 kg 3. 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 4. Having a history of fever in the preceding 24 h 5. Able to ingest tablets orally 6. Willing and able to attend stipulated follow-up visits 7. With written informed consent from parent/guardian for children to participate in the trial. Exclusion Criteria: Presenting with any of the following "danger signs of severe malaria": 1. Convulsions (\>1 episode within previous 24 hours) 2. Lethargic/unconscious

Locations (1)

Kibaha District

Kibaha, Tanzania

Outcomes

Primary Outcomes

Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine

during 42 days follow-up.

Data from ClinicalTrials.gov

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