Clinical trial NCT04383106: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute-On-Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients
timeFrame: Day 28
Secondary outcomes:
measure: Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.
timeFrame: Day 28
measure: Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients
timeFrame: Day 28
measure: Fecal carriage rates of C. difficile among hospitalized ACLF patients.
timeFrame: Day 28
measure: Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and duration
timeFrame: Day 28
measure: Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sites
timeFrame: Day 28
measure: Factors predisposing patients colonized with resistant bacterial species to develop extra-intestinal infectious events due to the same species
timeFrame: Day 28
measure: Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patients
timeFrame: Day 28
measure: Correlation of the fecal carriage rates of resistant bacterial species with etiology and severity of ACLF, including onset and resolution of organ failure (OF).
timeFrame: Day 28
measure: 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
timeFrame: Day 28
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: