Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile
- Conditions
- Clostridium Difficile
- Registration Number
- NCT01066221
- Lead Sponsor
- Hamilton Health Sciences Corporation
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- Patients older than 12 months of age
- Having diarrhea
- Inadequate volume of sample to perform all three diagnostic tests (less than 3mL
- Formed stools
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the performances of the three testing assays to see which one is the best. 6-8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada