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Completed

NCT Number: NCT01066221

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).

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Key information

Conditions

Clostridium Difficile

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To establish the performances of the three testing assays to see which one is the best.

    Time frame: 6-8 weeks

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University
  • St. Joseph's Healthcare Hamilton

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2010
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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