Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446355
Status:
COMPLETED
Last Update Posted:
2009-04-14
First Post:
2007-03-08
Brief Title:
Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor colectomy or secondary endpoints is associated with severe truncations 6 amino acid residues in TcdC a negative regulator of toxin AB production
2 Disease in low risk populations patients never exposed to health care facilities andor patients who never received antibiotics of any severity is attributable to strains of C difficile with severe tcdC truncation
1 Severe CDAD and tcdC truncation
Severe CDAD defined by death andor colectomy or secondary endpoints is associated with severe truncations 6 amino acid residues in TcdC a negative regulator of toxin AB production
2 Disease in low risk populations patients never exposed to health care facilities andor patients who never received antibiotics of any severity is attributable to strains of C difficile with severe tcdC truncation
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 outcomegender height weight ethnicity past medical history and outcomes We will collect information retrospectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None