Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania
Phase 4
Completed
- Conditions
- Malaria
- Registration Number
- NCT00454961
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- 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.
Exclusion Criteria
Presenting with any of the following "danger signs of severe malaria":
- Convulsions (>1 episode within previous 24 hours)
- Lethargic/unconscious
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine during 42 days follow-up.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kibaha District
🇹🇿Kibaha, Tanzania