Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00235664
First received: October 6, 2005
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

Infections caused by multidrug resistant bacteria have become more prevalent at many tertiary care and academic centers. These infections are associated with increased morbidity and mortality. The initial empiric antibiotic choice may not be adequate and delay in initiating appropriate therapy is a reason for poorer outcomes. Furthermore, not uncommonly the only therapeutic options available are associated with significant toxicity. This is a particular challenge for solid organ transplant recipients, who are immunosuppressed and have a higher risk of acquiring infections. Exposure to different classes of antibiotics has been linked to development of antibiotic resistance. Determining the risk factors for acquisition of drug-resistant bacteria and the molecular mechanisms by which resistance occurs would allow the development and implementation of strategies to minimize these infections and therefore improve outcomes. We, the researchers at the University of Pittsburgh, aim to collect surveillance cultures on patients undergoing liver, intestinal and multivisceral transplantation in order to determine the prevalence and risk factors for Pseudomonas aeruginosa (P. aeruginosa), extended-spectrum β-lactamases (ESBL)-Klebsiella and methicillin-resistant Staphylococcus aureus (MRSA), as well as determine the molecular mechanisms associated with the development of resistance in P. aeruginosa.


Condition Intervention
Transplantation
Procedure: Collection of stool and endotracheal aspirate samples

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients

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: 200
Study Start Date: October 2005
Study Completion Date: December 2007
Intervention Details:
    Procedure: Collection of stool and endotracheal aspirate samples
    collection of samples
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in ICU who are identified as having undergone liver, intestinal or multivisceral transplantation.

Criteria

Inclusion Criteria:

  • Patients in ICU who are identified as having undergone liver, intestinal or multivisceral transplantation. This includes cadaveric and living related liver transplants.
  • Patients must be above 18 years of age.
  • Patients undergoing re-transplantation may also be included.
  • Written informed consent from patient or a proxy.

Exclusion Criteria:

  • Known colonization or infection with multidrug resistant (MDR) P. aeruginosa, MRSA or ESBL-Klebsiella prior to admission to the ICU.
  • Pregnancy or nursing women
  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: NCT00235664

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: David Paterson, MD, UPMC
ClinicalTrials.gov Identifier: NCT00235664     History of Changes
Other Study ID Numbers: IRB# 0504102
Study First Received: October 6, 2005
Last Updated: December 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
liver transplant recipients
intestinal transplant recipients
multivisceral transplant recipients

ClinicalTrials.gov processed this record on October 01, 2014