- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00454961
Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania (C3)
October 24, 2007 updated by: Karolinska University Hospital
Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kibaha, Tanzania
- Kibaha District
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
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during 42 days follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anders Björkman, Professor, Karolinska University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Study Registration Dates
First Submitted
March 30, 2007
First Submitted That Met QC Criteria
March 30, 2007
First Posted (Estimate)
April 2, 2007
Study Record Updates
Last Update Posted (Estimate)
October 25, 2007
Last Update Submitted That Met QC Criteria
October 24, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCC-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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