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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06511492
Enrollment
1289
Registered
2024-07-22
Start date
2024-07-25
Completion date
2026-08-01
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver, Multidrug Resistance Organisms, Rectal Colonization

Brief 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.

Interventions

No intervention in this study

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of rectal colonization by MDROs in patients with cirrhosis90 daysThe prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization
The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers90 daysThe 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.

Secondary

MeasureTime frame
The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.90 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026