AzTrials
AzTrials

Liver DiseasesNCT00005667

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

An observational study of Liver Diseases, run by National Center for Research Resources (NCRR) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Diseases
How many people
Not given
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • 3316 Taubman Center, Box 0378 1500 E Medical Center Drive

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions
Liver Diseases
Keywords
liver transplantation, vancomycin resistance
Medical subject headings
Liver Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2000 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005667
Sponsor's protocol ID
NCRR-M01RR00042-1658
Other IDs
M01RR000042
Status last verified
Nov 2001
First submitted
19 May 2000
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Diseases, run by National Center for Research Resources (NCRR) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in