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Vancomycin Resistant Enterococci in Patients Awaiting Liver Transplantation at the University of Michigan: Prevalence, Risk Factors, Natural History and Outcome of Colonization

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ClinicalTrials.gov Identifier: NCT00005667
Recruitment Status : Unknown
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2000
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief Summary:
Enterococci, especially vancomycin resistant enterococci (VRE), are increasing in prevalence in many hospitals in the United States. Patients undergoing liver transplantation are at particular risk for developing infection due to VRE. The effect of prior colonization with VRE on the outcome of liver transplantation is unknown. This prospective study will ascertain the prevalence of gastrointestinal colonization with vancomycin resistant enterococci among patients awaiting liver transplantation at the University of Michigan Health System. Risk factors for acquisition of the organism, natural history of colonization and outcome in colonized patients will also be determined. All patients currently listed on a priority waiting list for liver transplantation at UMHS will be invited to participate. Patients will receive a standardized letter from their primary gastroenterologist describing the rationale for the study. Patients will be contacted by telephone by a member of the study team in order to arrange an appointment in the GCRC at the time of their regularly scheduled Transplant Clinic appointment in order discuss their potential participation in the study. Patients who give informed consent, will be interviewed using a standard interview questionnaire. Demographic and historical data relevant to the risk of VRE colonization will be collected during the interview. A sample will be obtained via rectal swab for culture. Rectal swabs for culture and collection of information on the standardized questionnaire will be repeated every six months while the patient is awaiting liver transplantation. When a patient undergoes liver transplantation, a culture will be obtained at the time of admission and weekly after post-operatively until discharge. All patients will be followed for 60 days after transplantation to assess several primary outcomes, including operative and post-operative complications, VRE infection and mortality. Rectal swabs will be the only procedure performed for the purposes of this study. Culture results will not be made available to the transplant team in order to avoid bias in clinical care. All data will be entered into an electronic database. GCRC statisticians will assist in the analysis of risk factors and outcome analysis.

Condition or disease
Liver Diseases

Study Design

Study Type : Observational
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective

Resource links provided by the National Library of Medicine

Drug Information available for: Vancomycin
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients 18 years or older currently listed on a priority waiting list for liver transplantation at the University of Michigan will be invited to participate.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005667

United States, Michigan
3316 Taubman Center, Box 0378 1500 E Medical Center Drive
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Center for Research Resources (NCRR)
More Information

ClinicalTrials.gov Identifier: NCT00005667     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1658
M01RR000042 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001

Keywords provided by National Center for Research Resources (NCRR):
liver transplantation
vancomycin resistance

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents