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.

NCT ID: NCT04383106

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute-On-Chronic Liver Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 39568042 (View on PubMed)

Other Identifiers

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ILBS-ACLF-10

Identifier Type: -

Identifier Source: org_study_id

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