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Mechanisms of Resistance and Molecular Epidemiology of Commonly Encountered Multi-Resistant Bacteria

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00275327
First received: January 9, 2006
Last updated: August 23, 2012
Last verified: August 2012

January 9, 2006
August 23, 2012
January 2006
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Complete list of historical versions of study NCT00275327 on ClinicalTrials.gov Archive Site
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Mechanisms of Resistance and Molecular Epidemiology of Commonly Encountered Multi-Resistant Bacteria
Mechanisms of Resistance and Molecular Epidemiology of Commonly Encountered Multi-Resistant Bacteria

o determine if extended-spectrum beta-lactamases, plasmid-mediated AmpC beta-lactamases, carbapenemases, chromosomal mutations in ribosomal RNA or other mechanisms of resistance account for antibiotic resistance in commonly encountered Gram negative and Gram positive bacteria at UPMC. Also to determine the molecular epidemiology and in vitro susceptibility of multiply resistant organisms at UPMC and to relate this to antibiotic use in the institution.

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 of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome gender, height, weight, ethnicity, and past medical history. 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 of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome gender, height, weight, ethnicity, and past medical history. The bacteria in the patient's 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). Patient data will be entered into a database by the honest brokers using an excel program for electronic data capture and reporting system. The honest brokers will have access to the database to ensure data integrity and perform data analyses. In addition, the Honest Broker will obtain information from the medical record as well as information about the specimens. The research team will have access to the database that is deidentified. The following evaluation will be performed on the bacteria. 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 molecular mechanisms of antibiotic resistance such as production of beta-lactamases. 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 investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time will the research investigators have access to any patient identifiers.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

Non-Probability Sample

isolates

Bacterial Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2015
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Inclusion Criteria:

  • bacteria resistant to commonly used antibiotics
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275327
IRB# 0510165
Yes
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Yohei Doi, MD University of Pittsburgh
University of Pittsburgh
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP