Antimicrobial Resistance in Acute Cholangitis (ARISE)

March 24, 2024 updated by: Bogdan Miutescu, MD, Emergency County Hospital Pius Brinzeu; Timisoara, Romania

Exploring Antimicrobial Resistance in Patients With Acute Cholangitis Undergoing ERCP: A Prospective Multicentre Study

This study prospectively explores antimicrobial resistance in patients with acute cholangitis undergoing ERCP procedures. By analyzing patient profiles, microbial cultures, and treatment outcomes, the current study seeks to identify specific patterns of resistance, assess the effectiveness of current antimicrobial therapies, and explore potential strategies to optimize treatment regimens.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Given the extensive utilization of antibiotics and the worldwide rise of multidrug-resistant organisms, there are ongoing initiatives to ascertain microbiological traits and discern patterns of drug resistance associated with intra-abdominal infections.

Microbial cultures from bile and blood samples will be established and characterized using appropriate methodologies. For patients with moderate and severe acute cholangitis (AC), blood cultures will be initiated upon admission, adhering to the Tokyo Guidelines for AC 2018 recommendations. Bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention. Initially, a minimum of 5 mL of the procured bile will be discarded, followed by the collection of an additional 5 mL in a sterile vessel containing a medium conducive to both anaerobic and aerobic bacterial cultures. The samples will undergo a minimum incubation period of seven days at 37 °C until microbial proliferation becomes evident. Antibiotic susceptibility assessments, specifically minimum inhibitory concentration (MIC), will be performed and interpreted according to established guidelines.The analysis of samples will occur within the laboratory of each respective center, with antibiograms conducted in accordance with established protocols.

Study Type

Observational

Enrollment (Estimated)

1700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the hospital with acute cholangitis undergoing ERCP as part of routine medical care.

Description

Inclusion Criteria:

  • Patients with acute cholangitis
  • Ability to provide an informed consent
  • Age over 18 years
  • Any gender

Exclusion Criteria:

  • Age under 18
  • Pregnancy
  • Post-ERCP perforation
  • The patient's decision to abstain from study enrollment
  • Patients unable to express informed consent
  • Patients from whom a bile sample could not be collected.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute cholangitis
Patients admitted to the hospital due to acute cholangitis and undergoing ERCP will be selected. Bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention.
Procedure: ERCP
ERCP will serve as the exclusive therapeutic modality, aided by a therapeutic duodenoscope to access the common bile duct using a guidewire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile
Time Frame: 2 years
The primary objective of this prospective, multicenter study is to meticulously characterize the bacterial profile and assess the antimicrobial resistance of bile cultures in patients diagnosed with acute cholangitis undergoing ERCP procedures. By employing advanced microbiological analyses, the investigators aim to identify specific bacterial strains and their resistance profiles, providing comprehensive insights into the dynamics of infection. This primary outcome will contribute to the development of tailored antimicrobial strategies, optimizing the management and treatment outcomes for individuals with acute cholangitis.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isolated bacteria and the etiology of obstructive biliary disease
Time Frame: 2 years
Secondary objectives encompass exploring the correlation between isolated bacteria and the etiology of obstructive biliary disease.
2 years
Multidrug-Resistance (MDR)
Time Frame: 2 years
Additionally, the investigators aim to determine the occurrence and frequency of multidrug-resistant (MDR) organisms and sentinel microorganisms in bile samples.
2 years
ERCP naive patients vs. patients with a history of ERCP
Time Frame: 2 years
Furthermore, the investigators are going to explore potential variations in the biliary microbial community, making comparisons between patients with no prior ERCP experience (naive) and those with a history of ERCP procedures. This comprehensive secondary outcome analysis seeks to unravel microbial relationships, antibiotic resistance patterns, and the impact of procedural history on biliary microbial communities in the context of acute cholangitis.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergency County Hospital Pius Brinzeu; Timisoara, Romania

Collaborators

Department of Gastroenterology, Clinical Emergency Hospital of Bucharest, Romania
Department 5, "Carol Davila" University of Medicine and Pharmacy, Romania
Department of Gastroenterology, "Grigore T. Popa" University of Medicine and Pharmacy, Romania

Investigators

  • Principal Investigator: Bogdan Miutescu, MD,PhD, Emergency County Hospital Pius Brinzeu; Timisoara, Romania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

January 5, 2026

Study Completion (Estimated)

January 5, 2026

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 407/29.09.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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