Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile

This study has been completed.
Sponsor:
Collaborators:
McMaster University
St. Joseph's Healthcare Hamilton
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01066221
First received: February 9, 2010
Last updated: July 19, 2011
Last verified: February 2010
  Purpose

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
Clostridium Difficile

Study Type: Observational
Study Design: 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

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To establish the performances of the three testing assays to see which one is the best. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 470
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Clostridium difficile patients
observational study

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hamilton Regional Laboratory Medicine Program - patients with clostridium difficile

Criteria

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
  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: NCT01066221

Locations
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
Investigators
Principal Investigator: Christine Lee, MD St. Joseph's Health Care London
  More Information

No publications provided

Responsible Party: Christine Lee, MD, McMaster University
ClinicalTrials.gov Identifier: NCT01066221     History of Changes
Other Study ID Numbers: 2010-001
Study First Received: February 9, 2010
Last Updated: July 19, 2011
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
clostridium difficile

ClinicalTrials.gov processed this record on October 23, 2014