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Completed

NCT Number: NCT06197984

Antimicrobial Resistance in Acute Cholangitis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ERCP

Procedure

ERCP will serve as the exclusive therapeutic modality, aided by a therapeutic duodenoscope to access the common bile duct using a guidewire.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Emergency County Hospital Pius Brinzeu; Timisoara, Romania

Network

Collaborators

  • Bucharest Emergency Hospital
  • Carol Davila University of Medicine and Pharmacy
  • Grigore T. Popa University of Medicine and Pharmacy

Registry information

Official study title

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

Acronym: ARISE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2024
Registry last updated
Apr 28, 2026

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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