NCT06197984

Antimicrobial Resistance in Acute Cholangitis

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,700 (estimated)
• Sponsor: Emergency County Hospital Pius Brinzeu; Timisoara, Romania · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-01-05
• Completion: 2026-01-05
• First posted: 2024-01-10
• Last updated: 2025-08-06

Locations

1 site across 1 country: Romania