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Resistant bacteria of stool causing infection at other sites in ACLF patients.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/05/025096
Enrollment
200
Registered
2020-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Acute on Chronic Liver Failure admitted to the ward/High Dependency Unit/Intensive Care Unit.

Exclusion criteria

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) 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.

Design outcomes

Primary

MeasureTime frame
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patientsTimepoint: Day 28

Secondary

MeasureTime frame
Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sitesTimepoint: Day 28;Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and durationTimepoint: 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 survivalTimepoint: 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).Timepoint: Day 28;Factors predisposing patients colonized with resistant bacterial species to develop extra-intestinal infectious events due to the same speciesTimepoint: Day 28;Fecal carriage rates of C. difficile among hospitalized ACLF patients.Timepoint: Day 28;Fecal isolation rates of ESBL producing gram negative bacterial species among hospitalized ACLF patientsTimepoint: Day 28;Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patientsTimepoint: Day 28;Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patientsTimepoint: Day 28

Countries

India

Contacts

Public ContactDr Vikram Bhatia

Institute of Liver and Biliary Sciences

vikrambhatiadr@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026