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

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00446355
First received: March 8, 2007
Last updated: April 12, 2009
Last verified: April 2009
  Purpose

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
Clostridium Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 1000
Study Start Date: February 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

CDAD confirmed

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446355

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

No publications provided

Responsible Party: Scott Curry, MD, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00446355     History of Changes
Other Study ID Numbers: PRO07010069
Study First Received: March 8, 2007
Last Updated: April 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
C diff
antibiotics

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

ClinicalTrials.gov processed this record on April 16, 2014