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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:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00454961
First received: March 30, 2007
Last updated: October 24, 2007
Last verified: October 2007
History of Changes
  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: 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:

MedlinePlus related topics: Malaria
U.S. FDA Resources

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454961

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

No publications provided by Karolinska University Hospital

Additional 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
Study First Received: March 30, 2007
Last Updated: October 24, 2007
Health Authority: Tanzania: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013