Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Clostridium Difficile

Study type: Observational

Funder types: Other

Identifiers

NCT01066221

2010-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 470 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

470 participants in 1 patient group

Clostridium difficile patients

Description:

observational study