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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: March 15, 2006
Last updated: December 16, 2015
Last verified: December 2015
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.

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 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
gram negative organisms

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 identifier: NCT00304330

Contact: David L Paterson, MD 412-648-6401
Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553

United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: David L Paterson, MD    412-648-6401   
Contact: Diana Lynn Pakstis, RN, BSN    412-648-6553   
Principal Investigator: David L Paterson, MD         
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: David L Paterson, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh Identifier: NCT00304330     History of Changes
Obsolete Identifiers: NCT00332423
Other Study ID Numbers: IRB# 0602123
Study First Received: March 15, 2006
Last Updated: December 16, 2015

Keywords provided by University of Pittsburgh:
gram negative infection processed this record on April 25, 2017