Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443885
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2007-03-05
Brief Title:
Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC to Problematic Gram-negative Organisms
Status:
COMPLETED
Status Verified Date:
2018-06
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 isolate samples will be collected over a period of one year once IRB approval has been obtained These isolates were collected as part of the patients clinical care and once all clinical testing is complete all isolates will be discarded The honest broker of our area will collect the isolates and deidentify all information once all clinical testing is complete The isolates will be obtained from the microbiology lab
Detailed Description:
The study will collect two hundred pseudomonas and 20 acinetobacter baumanti consecutive bacterial isolates from microbiology These isolates are collected as part of the patients clinical care and are discarded once all clinical testing is complete The honest broker will obtain these samples after all clinical testing is complete All isolates will be deidentified These isolates will be tested using standardized susceptibility methods for meropenem and imipenem The activity of doripenem a carbapenem currently being studied and arbekacin an aminoglycoside will also be tested The honest broker will also collect limited patient data including underlying condition presence of a solid organ transplant ward location and antibiotic history over the three months prior to organism isolation For resistant isolates found analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single sourcebeing transmitted from person to person
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