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

NCT00235664 | Completed

• 1 other identifier: IRB# 0504102
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplantation

Keywords

liver transplant recipients; intestinal transplant recipients; multivisceral transplant recipients

Interventions

Collection of stool and endotracheal aspirate samples PROCEDURE

collection of samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

Study Officials

• David L Paterson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: October 1, 2005
• Study Completion: December 1, 2007
• Last Updated: December 17, 2008

Record last verified: 2008-12

Locations

US (1)