Antimicrobial Resistance in Acute Cholangitis

NCT06197984 | Completed

• 1 other identifier: 407/29.09.2023
• Study Type: observational
• Target: 1,435
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Acute Cholangitis; Antibiotics; MultiDrug Resistance (MDR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Isolated bacteria and the etiology of obstructive biliary disease

  2 years

• Multidrug-Resistance (MDR)

  2 years

• ERCP naive patients vs. patients with a history of ERCP

  2 years

Study Arms (1)

Patients with acute cholangitis

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.

Procedure: ERCP

Interventions

ERCP PROCEDURE

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

Patients with acute cholangitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital with acute cholangitis undergoing ERCP as part of routine medical care.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergency County Hospital Pius Brinzeu; Timisoara, Romania: lead
• Carol Davila University of Medicine and Pharmacy: collaborator
• Grigore T. Popa University of Medicine and Pharmacy: collaborator
• Bucharest Emergency Hospital: collaborator

Study Sites (1)

Bogdan Miutescu

Timișoara, 300723, Romania

Location

MeSH Terms

Conditions

Biliary Tract Diseases; Jaundice; Jaundice, Obstructive; Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Bogdan Miutescu, MD,PhD

  Emergency County Hospital Pius Brinzeu; Timisoara, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: January 8, 2024
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)