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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.

I

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Acute-On-Chronic Liver Failure

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04383106
ILBS-ACLF-10

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Dr Satender Pal Singh, MD

Data sourced from clinicaltrials.gov

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