Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile

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. Identifier: NCT01066221
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : July 20, 2011
McMaster University
St. Joseph's Healthcare Hamilton
Information provided by:
McMaster University

Brief Summary:
The purpose of this study is to establish which of the following tests perform best in diagnosing clostridium difficile. PCR, Enzyme Immunoassays (EIA) and C. difficile cytotoxin assay (CTA).

Condition or disease
Clostridium Difficile

Detailed Description:
This comparative study will be carried out in the hospital microbiology laboratory of a tertiary academic health center, St. Joseph's Healthcare (SJH) affiliated with McMaster University, Hamilton, ON on 500 individual stool samples from patients greater than 12 months of age to determine an efficacy of distinction between current gold standard and other methods of testing for Clostridium difficile. This study is required to find a faster test for diagnosis of CDI in order to facilitate prompt treatment and reduce the complications of CDI. Identification of infected cases will lead to the enforcement of infection control measures and thereby prevent spread to other susceptible children. This is turn will reduce costs, length of stay, morbidity, and mortality from CDI if instituted correctly.

Study Type : Observational
Actual Enrollment : 470 participants
Time Perspective: Prospective
Official Title: Comparative Study of Enzyme Immunoassays:Techlab Toxins A&B, C Diff Quick Check for Glutamate Dehydrogenase (GDH);3 PCRs,and Cytotoxin Assay (CTA) for the Detection of Clostridium Difficile Toxin in Adult Stool Specimens
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Clostridium difficile patients
observational study

Primary Outcome Measures :
  1. To establish the performances of the three testing assays to see which one is the best. [ Time Frame: 6-8 weeks ]

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hamilton Regional Laboratory Medicine Program - patients with clostridium difficile

Inclusion Criteria:

  • Patients older than 12 months of age
  • Having diarrhea

Exclusion Criteria:

  • Inadequate volume of sample to perform all three diagnostic tests (less than 3mL
  • Formed stools

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 identifier (NCT number): NCT01066221

Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
St. Joseph's Healthcare Hamilton
Principal Investigator: Christine Lee, MD St. Joseph's Health Care London

Responsible Party: Christine Lee, MD, McMaster University Identifier: NCT01066221     History of Changes
Other Study ID Numbers: 2010-001
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: February 2010

Keywords provided by McMaster University:
clostridium difficile