Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177957
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2005-09-13
Brief Title:
Gram Negative Bacteremia Risk Factors for Failure of Therapy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Gram Negative Bacteremia Risk Factors for Failure of Therapy
Status:
COMPLETED
Status Verified Date:
2017-06
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 aims of this study are to
Determine the risk factors for multidrug resistance in bloodstream isolates of Gram negative bacilli
Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram negative bacilli
Determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria
Determine the survival of patients with Gram negative bacteremia
Determine if failure of prompt clearance of the blood of Gram negative bacteria is a predictor of mortality following this infection
Determine the risk factors for multidrug resistance in bloodstream isolates of Gram negative bacilli
Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram negative bacilli
Determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria
Determine the survival of patients with Gram negative bacteremia
Determine if failure of prompt clearance of the blood of Gram negative bacteria is a predictor of mortality following this infection
Detailed Description:
The following variables will be followed time and location of positive cultures underlying diseases and severity of illness recent immunomodulative therapies physical exam findings laboratory and radiographical data antimicrobial usage within 14 days of onset of bacteremia microbiological data and resistance patterns choice of antibiotics once organism identified suspected source of bacteremia bacteriological outcomes laboratory results demographic information medications clinical outcomegender height weight ethnicity and past medical history please see attached clinical data collection worksheet dated 42005 We will also collect information retrospectively for one year and prospectively for one year The bacteria in the patients blood cultures will be subcultured after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture and provided to the honest broker who will deidentify the specimen and link it to the medical information collected which will also be deidentified by the honest broker The following evaluation will be performed on these samples The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method AB Biodisk Solna Sweden Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases Biologic samples will be under the control of the principal investigator of this research project All samples provided to the investigators are deidentified by the honest broker and will be coded with numbers The information linking these code numbers to the corresponding subjects identities will be kept in a separate secure location that only the honest broker has access to The investigators on this study will keep the samples indefinitely Samples will be kept in the investigators laboratory located in Scaife Hall room 812 3500 Terrace Street At no time with the research investigators have access to any patient identifiers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None