Bowel Colonization With Multi-drug Resistant Bacterial Sp... | NCT04383106

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Apr 22, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2024

Last Update Posted Date

Mar 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients		Day 28

Secondary Outcomes

Measure	Description	Time Frame
Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.		Day 28
Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver and Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39568042	Derived	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.

ID	Term
D017114	Liver Failure, Acute
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases