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Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile

NCT ID: NCT01066221

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Clostridium Difficile

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Clostridium difficile patients

observational study

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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McMaster University

Principal Investigators

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Christine Lee, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care London

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2010-001

Identifier Type: -

Identifier Source: org_study_id

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