Acute-On-Chronic Liver FailureNCT04383106
Bowel Colonization With Multi-drug Resistant Bacterial Species in Hospitalized Patients With acute-on Chronic Liver Failure (ACLF), and Its Relationship With Extra-intestinal Infectious Events and Short-term Outcomes.
An observational study of Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Bowel colonization with anti-microbial resistant bacteria increases the risk of clinical infections. Infections caused by anti-microbial resistant bacteria have been associated with increased mortality, prolonged hospital stay, and increased costs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2020to 31 Dec 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients admitted to the Institute of Liver and Biliary Sciences (ILBS) with Acute on Chronic Liver Failure (ACLF) will be evaluated for inclusion. ACLF will be defined by the Asian Pacific association for the Study of Liver Disease (APASL) criteria.
Who may be able to join
- Patients with Acute on Chronic Liver Failure admitted to the ward/High Dependency Unit/Intensive Care Unit.
Who cannot join
- Patients on immunosuppressant medications or on daily steroids (excluding inhaled steroids) or >2 weeks.
- Patients with additional primary or acquired immunosuppressive states like hypogammaglobinemia, post-splenectomy, human immunodeficiency virus (HIV) infection etc.
- Neutropenia defined as absolute neutrophil count or total white blood cell count (WBC) <500/mm3
- Patients with extra-hepatic malignancy or on cytotoxic chemotherapy.
- Patients with ileus, bowel hypomotility, severe constipation requiring laxatives/purgatives or enemas to evacuate.
- Patients with fresh or altered blood in stools.
- Patients with anatomical predisposition to infection/ bacterial seeing like prosthesis or foreign body. Patients with exfoliative skin conditions, significant mucosal ulcerations, or skin ulcers. Patients who have received > 2 weeks of antibiotics before current admission.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Bowel colonization with anti-microbial resistant bacteria increases the risk of clinical infections. Infections caused by anti-microbial resistant bacteria have been associated with increased mortality, prolonged hospital stay, and increased costs. In addition, with the emergence of carbapenemase resistant bacterial species, there may not be any effective therapy for patients infected with such resistant species.
Bowel colonization with anti-microbial resistant bacteria is an established risk factor for infections due to resistant bacteria, especially in transplanted patients and in intensive care unit. In this study we will study whether bowel colonisation in Acute on Chronic Liver Failure patient increases the risk of infection development in extra intestinal sites.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- no intervention
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients
Measured: Day 28
Secondary outcomes (9)
Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.
Measured: Day 28
Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients
Measured: Day 28
Fecal carriage rates of C. difficile among hospitalized ACLF patients.
Measured: Day 28
Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and duration
Measured: Day 28
Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sites
Stool culture sensitivity organism concordance will be checked with culture organism from other sites like blood, urine, ascitic, pleural, skin.
Measured: Day 28
Factors predisposing patients colonized with resistant bacterial species to develop extra-intestinal infectious events due to the same species
Factors will be assessed like previous hospitalisation, days of hospital stay, severity of disease, number and type and dosage of antibiotics usage in previous hospitalisation and current hospital stay, other symptom localisation of extraintestinal sites like lung infection, abdominal infection, urine infection, skin infection
Measured: Day 28
Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patients
Measured: Day 28
Correlation of the fecal carriage rates of resistant bacterial species with etiology and severity of ACLF, including onset and resolution of organ failure (OF).
Measured: Day 28
Correlation of fecal carriage resistant bacterial species with patient outcomes (admission duration or survival duration, short-term survival to discharge, readmission rates, and 30-day survival
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383106
- Sponsor's protocol ID
- ILBS-ACLF-10
- Status last verified
- Mar 2024
- First submitted
- 22 Apr 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh SP, Bhatia V, Kale P, Kumar G, Khillan V, Vijayaraghavan R. Bowel Colonization With Carbapenem-Resistant Bacteria Is Associated With Short-Term Outcomes in Patients With Acute-On-Chronic Liver Failure. J Gastroenterol Hepatol. 2025 Feb;40(2):528-536. doi: 10.1111/jgh.16830. Epub 2024 Nov 20.
PubMed 39568042
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Colonization With Multi-drug Resistant Bacterial Species in Hospitalized Patients With acute-on Chronic Liver Failure (ACLF), and Its Relationship With Extra-intestinal Infectious Events and Short-term Outcomes.
- ClinicalTrials.gov ID
- NCT04383106
- Acronym / sponsor ID
- ILBS-ACLF-10
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 May 2020 (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.
Bowel colonization with anti-microbial resistant bacteria increases the risk of clinical infections. Infections caused by anti-microbial resistant bacteria have been associated with increased mortality, prolonged hospital stay, and increased costs. In addition, with the emergence of carbapenemase resistant bacterial species, there may not be any effective therapy for patients infected with such resistant species.
Bowel colonization with anti-microbial resistant bacteria is an established risk factor for infections due to resistant bacteria, especially in transplanted patients and in intensive care unit. In this study we will study whether bowel colonisation in Acute on Chronic Liver Failure patient increases the risk of infection development in extra intestinal sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients admitted to the Institute of Liver and Biliary Sciences (ILBS) with Acute on Chronic Liver Failure (ACLF) will be evaluated for inclusion. ACLF will be defined by the Asian Pacific association for the Study of Liver Disease (APASL) criteria.
Key inclusion criteria (1 listed)
- Patients with Acute on Chronic Liver Failure admitted to the ward/High Dependency Unit/Intensive Care Unit.
Key exclusion criteria (8 listed)
- Patients on immunosuppressant medications or on daily steroids (excluding inhaled steroids) or >2 weeks.
- Patients with additional primary or acquired immunosuppressive states like hypogammaglobinemia, post-splenectomy, human immunodeficiency virus (HIV) infection etc.
- Neutropenia defined as absolute neutrophil count or total white blood cell count (WBC) <500/mm3
- Patients with extra-hepatic malignancy or on cytotoxic chemotherapy.
- Patients with ileus, bowel hypomotility, severe constipation requiring laxatives/purgatives or enemas to evacuate.
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 interventionno intervention | Other | – |
Primary outcome
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients
Time frame: Day 28
9 secondary outcomes
Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.
Time frame: Day 28
Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients
Time frame: Day 28
Fecal carriage rates of C. difficile among hospitalized ACLF patients.
Time frame: Day 28
Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and duration
Time frame: Day 28
Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sites
Time frame: Day 28
Factors predisposing patients colonized with resistant bacterial species to develop extra-intestinal infectious events due to the same species
Time frame: Day 28
Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patients
Time frame: Day 28
Correlation of the fecal carriage rates of resistant bacterial species with etiology and severity of ACLF, including onset and resolution of organ failure (OF).
Time frame: Day 28
Correlation of fecal carriage resistant bacterial species with patient outcomes (admission duration or survival duration, short-term survival to discharge, readmission rates, and 30-day survival
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 39568042Singh SP, Bhatia V, Kale P, Kumar G, Khillan V, Vijayaraghavan R. Bowel Colonization With Carbapenem-Resistant Bacteria Is Associated With Short-Term Outcomes in Patients With Acute-On-Chronic Liver Failure. J Gastroenterol Hepatol. 2025 Feb;40(2):528-536. doi: 10.1111/jgh.16830. Epub 2024 Nov 20.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383106, which also lists 1 linked publication.
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 5 Mar 2024.