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Use of Rapid Diagnostic Tests for Malaria Case Management in Kenya

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ClinicalTrials.gov Identifier: NCT00336388
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : March 9, 2010
Sponsor:
Collaborators:
Kenya Medical Research Institute
Kenya Division of Malaria Control
KEMRI-Wellcome Trust Collaborative Research Program
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
The purpose of this study is to investigate the impact of rapid diagnostic tests (RDTs) in the context of a newly implemented malaria case management guidelines using artemisinin-based combination therapy on the malaria prescribing practices of health care workers in Kenya.

Condition or disease Intervention/treatment Phase
Malaria Device: Paracheck Device Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Introduction of Malaria Rapid Diagnostic Tests, Artemisinin-based Combination Therapy, and Malaria Case Management Guidelines at Health Facilities in Kenya: A Cluster Randomized Trial to Evaluate Adherence and Acceptance by Health Care Workers, Impact on Antimalarial Prescription Practices, and Patient Perceptions
Study Start Date : July 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. Sensitivity and specificity of malaria diagnosis 6 weeks after the introduction of malaria rapid diagnostic tests

Secondary Outcome Measures :
  1. Adherence to malaria case management guidelines by health care workers
  2. Cost effectiveness of malaria case management guidelines using malaria rapid diagnostic tests
  3. Acceptability of malaria rapid diagnostic tests to health care workers
  4. Acceptability of malaria rapid diagnostic tests to patients


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All ill persons >5 years old attending health facilities in Bondo and Kericho Districts, Kenya

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): NCT00336388


Locations
Kenya
Bondo and Kericho District Health Facilities
Kisumu, Nyanza Province, Kenya
Sponsors and Collaborators
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Kenya Division of Malaria Control
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
Principal Investigator: Mary Hamel, MD Centers for Disease Control and Prevention
Principal Investigator: Alexandre Macedo De Oliveira, MD Centers for Disease Control and Prevention

Publications:
ClinicalTrials.gov Identifier: NCT00336388     History of Changes
Other Study ID Numbers: CDC-NCID-4701
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Centers for Disease Control and Prevention:
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases