Status:
COMPLETED
Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania
Lead Sponsor:
Karolinska University Hospital
Conditions:
Malaria
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- Presenting with any of the following "danger signs of severe malaria":
- Convulsions (\>1 episode within previous 24 hours)
- Lethargic/unconscious
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00454961
Start Date
April 1 2007
Last Update
October 25 2007
Active Locations (1)
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1
Kibaha District
Kibaha, Tanzania