Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile
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).
|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|
- 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 ]
|Study Start Date:||September 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Clostridium difficile patients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066221
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Christine Lee, MD||St. Joseph's Health Care London|