Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446355
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : April 14, 2009
Information provided by:
University of Pittsburgh

Brief Summary:

The purpose of the study is to establish the clinical disease outcomes and features of CDAD associated with variant tcdC genotypes. Two hypotheses are to be tested in this study:

  1. Severe CDAD and tcdC truncation:

    Severe CDAD (defined by death and/or colectomy or secondary endpoints) is associated with severe truncations (> 6 amino acid residues) in TcdC, a negative regulator of toxin A/B production.

  2. Disease in low risk populations (patients never exposed to health care facilities and/or patients who never received antibiotics) of any severity is attributable to strains of C. difficile with severe tcdC truncation.

Condition or disease
Clostridium Infections

Detailed Description:
The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), date of specimen collection, presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 6 months of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, past medical history and outcomes. We will collect information retrospectively.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes
Study Start Date : February 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CDAD confirmed

Inclusion Criteria:

  • All patients who have confirmed CDAD, confirmed by testing at UPMC's clinical microbiology lab in March 1, 2001- December 31, 2005 for C. difficile by stool toxin test with subsequent positive culture for the organism from inpatients/outpatients at UPMC Presbyterian-Montefiore, from WPIC inpatient units, from ER visits at the Presbyterian University Hospital emergency department, and from clinics closely affiliated with UPMC Presbyterian (medical and surgical clinics in Falk Clinic, the 9 South Montefiore internal medicine clinic, the geriatrics clinic in Montefiore, and the digestive disorders center (GI clinic on 3rd floor of PUH).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446355

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Scott Curry, MD University of Pittsburgh
Study Director: Lee Harrison, MD University of Pittsburgh

Responsible Party: Scott Curry, MD, University of Pittsburgh Medical Center Identifier: NCT00446355     History of Changes
Other Study ID Numbers: PRO07010069
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: April 14, 2009
Last Verified: April 2009

Keywords provided by University of Pittsburgh:
C diff

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections