Clinical trial NCT06511492: Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis
Official title: Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis: a Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cirrhosis, Liver
Rectal Colonization
Multidrug Resistance Organisms
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 1289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhosis patients with acute decompensation

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.


Eligibility criteria: 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;

Primary outcomes:
measure: The prevalence of rectal colonization by MDROs in patients with cirrhosis
timeFrame: 90 days
measure: The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers
timeFrame: 90 days
Secondary outcomes:
measure: The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: