Cirrhosis, LiverNCT06511492
Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis
An observational study of Cirrhosis, Liver and Rectal Colonization, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Liver, Rectal Colonization, Multidrug Resistance Organisms
- How many people
- 1,289 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2024to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhosis patients with acute decompensation
Who may be able to join
- Age>18 years old;
- Inpatients;
- Cirrhosis patients with acute decompensation;
Who cannot join
- 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;
About this study
Official title: Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis: a Cohort Study
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.
- Being tested
- No intervention in this study
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this studyOther
No intervention in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of rectal colonization by MDROs in patients with cirrhosis
The prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start25 Jul 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511492
- Sponsor's protocol ID
- NFEC-2023-469
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis: a Cohort Study
- ClinicalTrials.gov ID
- NCT06511492
- Acronym / sponsor ID
- NFEC-2023-469
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,289 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis patients with acute decompensation
Key inclusion criteria (3 listed)
- Age>18 years old;
- Inpatients;
- Cirrhosis patients with acute decompensation;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention in this studyNo intervention in this study | Other | – |
Primary outcome
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
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.
1 secondary outcome
The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Rectal Colonization, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of rectal colonization by MDROs in patients with cirrhosis (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.