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.

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 Overview

• Status: Completed
• Conditions: Acute-On-Chronic Liver Failure
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

• Study Contact: Name: Dr Satender Pal Singh, MD; Phone Number: 01146300000; Email: ama.satender@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients on immunosuppressant medications or on daily steroids (excluding inhaled steroids) or >2 weeks.
2. Patients with additional primary or acquired immunosuppressive states like hypogammaglobinemia, post-splenectomy, human immunodeficiency virus (HIV) infection etc.
3. Neutropenia defined as absolute neutrophil count or total white blood cell count (WBC) <500/mm3
4. Patients with extra-hepatic malignancy or on cytotoxic chemotherapy.
5. Patients with ileus, bowel hypomotility, severe constipation requiring laxatives/purgatives or enemas to evacuate.
6. Patients with fresh or altered blood in stools.
7. 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.
8. Pregnant patients.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Stool culture sensitivity organism concordance will be checked with culture organism from other sites like blood, urine, ascitic, pleural, skin.	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	Day 28
Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patients		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).		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		Day 28

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: ILBS-ACLF-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No