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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454961
First Posted: April 2, 2007
Last Update Posted: October 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karolinska University Hospital
  Purpose
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 Intervention Phase
Malaria Drug: artemether-lumefantrine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
  • during 42 days follow-up.

Estimated Enrollment: 200
Study Start Date: April 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454961


Locations
Tanzania
Kibaha District
Kibaha, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Study Director: Anders Björkman, Professor Karolinska University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00454961     History of Changes
Other Study ID Numbers: CCC-2007
First Submitted: March 30, 2007
First Posted: April 2, 2007
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by Karolinska University Hospital:
Malaria
Plasmodium falciparum
artemether-lumefantrine
effectiveness

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics