Antimicrobial Resistance in Acute Cholangitis

Last updated: March 24, 2024
Sponsor: Emergency County Hospital Pius Brinzeu; Timisoara, Romania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disease

Liver Disorders

Treatment

ERCP

Clinical Study ID

NCT06197984
407/29.09.2023
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 1700
Treatment Group(s): 1
Primary Treatment: ERCP
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
January 05, 2026

Study 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.

Connect with a study center

  • Bogdan Miutescu

    Timisoara, 300723
    Romania

    Active - Recruiting

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