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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on October 01, 2014