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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Conditions

Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients

    Time frame: Day 28

Secondary outcomes

  1. Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.

    Time frame: Day 28

  2. Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients

    Time frame: Day 28

  3. Fecal carriage rates of C. difficile among hospitalized ACLF patients.

    Time frame: Day 28

  4. Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and duration

    Time frame: Day 28

  5. Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sites

    Time frame: Day 28

    Stool culture sensitivity organism concordance will be checked with culture organism from other sites like blood, urine, ascitic, pleural, skin.

  6. Factors predisposing patients colonized with resistant bacterial species to develop extra-intestinal infectious events due to the same species

    Time frame: Day 28

    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

  7. Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patients

    Time frame: Day 28

  8. Correlation of the fecal carriage rates of resistant bacterial species with etiology and severity of ACLF, including onset and resolution of organ failure (OF).

    Time frame: Day 28

  9. 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

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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