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

NCT06511492 | Not Yet Recruiting DMC

• 1 other identifier: NFEC-2023-469
• Study Type: observational
• Target: 1,289
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis, Liver; Rectal Colonization; Multidrug Resistance Organisms

Outcome Measures

Primary Outcomes (2)

• The prevalence of rectal colonization by MDROs in patients with cirrhosis

  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

  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 Outcomes (1)

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

  90 days

Interventions

No intervention in this study OTHER

No intervention in this study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis patients with acute decompensation

You may qualify if:

• Age\>18 years old;
• Inpatients;
• Cirrhosis patients with acute decompensation;

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 25, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share