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.

NCT04383106 | Completed

• 1 other identifier: ILBS-ACLF-10
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients

  Day 28

Secondary Outcomes (9)

• Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.

  Day 28

• Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients

  Day 28

• Fecal carriage rates of C. difficile among hospitalized ACLF patients.

  Day 28

• Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and duration

  Day 28

• Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sites

  Day 28

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- Patients with Acute on Chronic Liver Failure admitted to the ward/High Dependency Unit/Intensive Care Unit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 39568042 DERIVED

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 12, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

IN (1)