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NCT Number: NCT06511492

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;

Treatment and study plan

No intervention in this study

Other

No intervention in this study

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

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

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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