Clinical trial NCT06197984: Antimicrobial Resistance in Acute Cholangitis
Official title: Exploring Antimicrobial Resistance in Patients With Acute Cholangitis Undergoing ERCP: A Prospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangitis Acute
Biliary Tract Diseases
Jaundice; Malignant
Jaundice, Obstructive
Choledocholithiasis
Keywords: Acute Cholangitis
Antibiotics
MultiDrug Resistance (MDR)
Lead sponsor: Emergency County Hospital Pius Brinzeu; Timisoara, Romania
Sponsor class: NETWORK
Collaborators: name: Department of Gastroenterology, Clinical Emergency Hospital of Bucharest, Romania
name: Department 5, "Carol Davila" University of Medicine and Pharmacy, Romania
name: Department of Gastroenterology, "Grigore T. Popa" University of Medicine and Pharmacy, Romania
First posted: 2024-01-10
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital with acute cholangitis undergoing ERCP as part of routine medical care.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile
timeFrame: 2 years
Secondary outcomes:
measure: Isolated bacteria and the etiology of obstructive biliary disease
timeFrame: 2 years
measure: Multidrug-Resistance (MDR)
timeFrame: 2 years
measure: ERCP naive patients vs. patients with a history of ERCP
timeFrame: 2 years
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Bogdan Miutescu
Study officials:
affiliation: Emergency County Hospital Pius Brinzeu; Timisoara, Romania
name: Bogdan Miutescu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: