NCT01066221

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 20, 2011

Status Verified

February 1, 2010

Enrollment Period

6 months

First QC Date

February 9, 2010

Last Update Submit

July 19, 2011

Conditions

Clostridium Difficile

Keywords

clostridium difficile

Outcome Measures

Primary Outcomes (1)

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

    6-8 weeks

Study Arms (1)

Clostridium difficile patients

observational study

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hamilton Regional Laboratory Medicine Program - patients with clostridium difficile

You may qualify if:

  • Patients older than 12 months of age
  • Having diarrhea

You may not qualify if:

  • Inadequate volume of sample to perform all three diagnostic tests (less than 3mL
  • Formed stools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Study Officials

  • Christine Lee, MD

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

July 20, 2011

Record last verified: 2010-02

Locations

CA(1)