Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 200
- Locations
- 1
Study Overview
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.
Detailed Description
Methods:
Day 1 is when patients are admitted to the Transplant intensive care unit (ICU) following liver, intestinal or multivisceral transplantation. Stool samples (in the case of patients with rectal bags and/or diarrhea) for cefotaxime-resistant Gram negative rods would be obtained within 24 hours of admission to the ICU and weekly thereafter until discharge from the hospital or isolation of MDR P. aeruginosa and ESBL- K. pneumoniae, whichever occurs first. While patients are intubated, endotracheal aspirates would also be obtained on a weekly basis. Nasal swabs for MRSA would be obtained within 24 hours of admission to the ICU and weekly thereafter until discharge from the hospital or isolation of MRSA, whichever comes first.
If there are no bowel movements on the days that stool is to be collected, a rectal swab will be obtained. In addition, if the endotracheal tube is pulled, no further endotracheal aspirates will be obtained. Samples will only be obtained if available. If the swab obtained on day 1 is positive for the organisms being studied, no further samples will be obtained.
No pregnancy testing will occur since all potential patients undergoing transplant must not be pregnant. Pregnant women, or women who are currently breast-feeding an infant, will not be allowed to take part in this study.
Once a drug-resistant organism (MDR P. aeruginosa, ESBL K. pneumoniae and/or MRSA) is isolated, skin swabs from the groin and subclavian areas will be obtained once. No further swabs will be obtained from the patient but he/she will be followed clinically to determine the impact of the organism on the patient's clinical outcome.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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