Antimicrobial Resistance in Acute Cholangitis

Choledocholithiasis Clinical Trial

— ARISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197984
• Other study ID #: 407/29.09.2023
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: January 5, 2026

Study information

• Verified date: March 2024
• Source: Emergency County Hospital Pius Brinzeu; Timisoara, Romania
• Contact: Bogdan Miutescu, MD, PhD
• Phone: 0356433111
• Email: bmiutescu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: January 5, 2026
• Est. primary completion date: January 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Cholangitis
• Choledocholithiasis
• Jaundice
• Jaundice, Obstructive
• Jaundice; Malignant

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.

Locations

Country	Name	City	State
Romania	Bogdan Miutescu	Timisoara

Sponsors (4)

Lead Sponsor	Collaborator
Emergency County Hospital Pius Brinzeu; Timisoara, Romania	Department 5, "Carol Davila" University of Medicine and Pharmacy, Romania, Department of Gastroenterology, "Grigore T. Popa" University of Medicine and Pharmacy, Romania, Department of Gastroenterology, Clinical Emergency Hospital of Bucharest, Romania

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile	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	Isolated bacteria and the etiology of obstructive biliary disease	Secondary objectives encompass exploring the correlation between isolated bacteria and the etiology of obstructive biliary disease.	2 years
Secondary	Multidrug-Resistance (MDR)	Additionally, the investigators aim to determine the occurrence and frequency of multidrug-resistant (MDR) organisms and sentinel microorganisms in bile samples.	2 years
Secondary	ERCP naive patients vs. patients with a history of ERCP	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