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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
  Purpose

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.


Condition
Bacterial Infection

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Mechanisms of Resistance and Molecular Epidemiology of Commonly Encountered Multi-Resistant Bacteria

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 300
Study Start Date: January 2006
Estimated Study Completion Date: December 2015
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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

isolates

Criteria

Inclusion Criteria:

  • bacteria resistant to commonly used antibiotics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275327

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Yohei Doi, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00275327     History of Changes
Other Study ID Numbers: IRB# 0510165
Study First Received: January 9, 2006
Last Updated: August 23, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
antibiotics

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on November 27, 2014