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Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00304330
First received: March 15, 2006
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

The information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population. Data is needed regarding the date of admission, date of bloodstream infection and location of ward/ICU so trends in the emergence of resistance and antibiotic usage can be detected.


Condition
Gram Negative Infection

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients; a Comparative Study With a Non-transplant Population

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: 1000
Study Start Date: September 2006
Estimated Study Completion Date: December 2015
Detailed Description:

We need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. We also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history

  Eligibility

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

gram negative organisms

Criteria

Inclusion Criteria:

  • All patients with a positive blood culture isolate growing a gram-negative organism will be included from 1996 - 2005
  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: NCT00304330

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00304330     History of Changes
Obsolete Identifiers: NCT00332423
Other Study ID Numbers: IRB# 0602123
Study First Received: March 15, 2006
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
gram negative infection

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on November 20, 2014