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Not yet recruitingNCT06511492Updated Jul 22, 2024

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

An observational study in Cirrhosis, Liver, Rectal Colonization and Multidrug Resistance Organisms, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,289
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cirrhosis, Liver
  • Rectal Colonization
  • Multidrug Resistance Organisms
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 1,289 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cirrhosis patients with acute decompensation

Inclusion criteria

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

Exclusion criteria

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;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,289 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention in this study

    No intervention in this study

06

What researchers measure

Primary outcomes

  1. The prevalence of rectal colonization by MDROs in patients with cirrhosis

    The prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization

    Time frame: 90 days

  2. The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers

    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.

    Time frame: 90 days

Secondary outcomes

  1. The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.

    Time frame: 90 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511492
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jul 22, 2024
Start date
Jul 25, 2024 (estimated)
Primary completion
Aug 30, 2025 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jul 22, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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