Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile

Clostridium Difficile Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066221
• Other study ID #: 2010-001
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: July 19, 2011
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: February 2010
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Clostridium Difficile

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the performances of the three testing assays to see which one is the best.		6-8 weeks	No