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Use of Rapid Diagnostic Tests for Malaria Case Management in Kenya

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00336388
First received: June 10, 2006
Last updated: March 8, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention
Malaria
 Device: Paracheck Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

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

Secondary Outcome Measures:
  • Adherence to malaria case management guidelines by health care workers
  • Cost effectiveness of malaria case management guidelines using malaria rapid diagnostic tests
  • Acceptability of malaria rapid diagnostic tests to health care workers
  • Acceptability of malaria rapid diagnostic tests to patients

Estimated Enrollment: 3600
Study Start Date: July 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All ill persons >5 years old attending health facilities in Bondo and Kericho Districts, Kenya
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00336388     History of Changes
Other Study ID Numbers: CDC-NCID-4701
Study First Received: June 10, 2006
Last Updated: March 8, 2010
Health Authority: United States: Federal Government
Kenya: Kenya Medical Research Institute

Keywords provided by Centers for Disease Control and Prevention:
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 22, 2013