Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis

July 16, 2024 updated by: Nanfang Hospital, Southern Medical University

Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis: a Cohort Study

Antimicrobial resistance has emerged as a global threat, and multidrug resistance organisms (MDROs) form one of the foremost challenges in the setting of decompensated cirrhosis. In a worldwide study, a high prevalence (34%) of infection with MDR bacteria in patients with cirrhosis and associated with higher in-hospital mortality.

Previous study indicated that the pattern of colonized bacteria in heterogeneous and the colonization by MDROs is associated with increased risk of infection. Effort should be made to reduce the spread of MDR bacteria and improvement in prognosis in patents with cirrhosis. Currently, strategies suggested to prevent the spread of MDROs in cirrhosis, including rapid microbiological tests, new first-line antibiotic schedules, infection control practices and epidemiological surveillance.

Thus, for the aims of this cohort study are as following. Firstly, to characterize the burden, dynamics and risk factors associated with rectal colonization by MDROs in patients with cirrhosis. Secondly, to completely characterize the risk that asymptomatic carriers of MDROs, both to other patients and to themselves via collecting detailed longitudinal sampling and high-resolution typing. Lastly, to generate evidence for future policymaking for individualized antimicrobial decision rather than umbrella guidelines since the variance in the bacteriological profiles in different settings.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cirrhosis patients with acute decompensation

Description

Inclusion Criteria:

  1. Age>18 years old;
  2. Inpatients;
  3. Cirrhosis patients with acute decompensation;

Exclusion Criteria:

  1. Patients decline any swab type;
  2. Patients had liver resection or other organ transplantation;
  3. Patients who had participated in, or are planning to participate in other clinical trial within the 3 months prior to enrollment;
  4. Hospital stays <48 hours;
  5. Not suitable to participate in this study judging by researchers;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of rectal colonization by MDROs in patients with cirrhosis
Time Frame: 90 days
The prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization
90 days
The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers
Time Frame: 90 days
The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers and describe the risk of colonization both to other patients and to themselves.
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2024

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2023-469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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