Antimicrobial Resistance in Acute Cholangitis (ARISE)

Emergency County Hospital Pius Brinzeu; Timisoara, Romania

Status: Enrolling

Conditions: Jaundice, Obstructive; Jaundice; Malignant; Cholangitis Acute; Choledocholithiasis; Biliary Tract Diseases

Treatments: Procedure: ERCP

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT06197984

407/29.09.2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,700 participants in 1 patient group

Patients with acute cholangitis

Description:

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.

Treatment:

Procedure: ERCP