C3: Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00454961

Collaborator

(none)

200

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: artemether-lumefantrine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania

Study Start Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine []
during 42 days follow-up. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.