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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00446355 |
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:
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.
Condition |
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Clostridium Infections |
Study Type: | Observational |
Study Design: | Case Control, Retrospective |
Official Title: | Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
CDAD confirmed
Inclusion Criteria:
Contact: Scott Curry, MD | 412-648-9704 | currysr@upmc.edu |
Contact: Lee Harrison, MD | 412-648-6401 | lharriso@edc.pitt.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Scott Curry, MD 412-648-9704 currysr@upmc.edu | |
Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
Principal Investigator: Scott Curry, MD |
Principal Investigator: | Scott Curry, MD | University of Pittsburgh |
Study Director: | Lee Harrison, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Medical Center ( Scott Curry, MD ) |
Study ID Numbers: | PRO07010069 |
Study First Received: | March 8, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00446355 |
Health Authority: | United States: Institutional Review Board |
C diff antibiotics |
Bacterial Infections Gram-Positive Bacterial Infections Clostridium Infections |
Infection |