Cholangitis AcuteARISENCT06197984
Antimicrobial Resistance in Acute Cholangitis
An observational study of Cholangitis Acute and Biliary Tract Diseases, run by Emergency County Hospital Pius Brinzeu; Timisoara, Romania at 1 site in Romania.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangitis Acute, Biliary Tract Diseases, Jaundice; Malignant
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 1,435 participants
- Where
- 1 siteRomania
- Study dates
- 8 Jan 2024to 5 Jan 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital with acute cholangitis undergoing ERCP as part of routine medical care.
Who may be able to join
- Patients with acute cholangitis
- Ability to provide an informed consent
- Age over 18 years
- Any gender
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Antimicrobial Resistance in Patients With Acute Cholangitis Undergoing ERCP: A Prospective Multicentre Study
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.
Read the 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
- Being tested
- ERCP
- Keywords
- Acute Cholangitis, Antibiotics, MultiDrug Resistance (MDR)
- Medical subject headings
- Biliary Tract Diseases, Jaundice, Jaundice, Obstructive, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
ERCP will serve as the exclusive therapeutic modality, aided by a therapeutic duodenoscope to access the common bile duct using a guidewire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
Multidrug-Resistance (MDR)
Additionally, the investigators aim to determine the occurrence and frequency of multidrug-resistant (MDR) organisms and sentinel microorganisms in bile samples.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start8 Jan 2024
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,435 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Emergency County Hospital Pius Brinzeu; Timisoara, Romania
- Sponsor type
- Research network
- Collaborators
- Carol Davila University of Medicine and Pharmacy, Grigore T. Popa University of Medicine and Pharmacy, Bucharest Emergency Hospital
- Responsible party
- Principal investigator, Bogdan Miutescu, MD, Emergency County Hospital Pius Brinzeu; Timisoara, Romania
- Investigators
- Bogdan Miutescu, MD,PhD, Principal investigator, Emergency County Hospital Pius Brinzeu; Timisoara, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197984
- Sponsor's protocol ID
- 407/29.09.2023
- Acronym
- ARISE
- Status last verified
- Apr 2026
- First submitted
- 26 Dec 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Antimicrobial Resistance in Patients With Acute Cholangitis Undergoing ERCP: A Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT06197984
- Acronym / sponsor ID
- ARISE / 407/29.09.2023
- Conditions
- Cholangitis Acute, Biliary Tract Diseases, Jaundice; Malignant, Jaundice, Obstructive, Choledocholithiasis
- Keywords
- Acute Cholangitis, Antibiotics, MultiDrug Resistance (MDR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,435 participants (actual)
- Lead sponsor
- Emergency County Hospital Pius Brinzeu; Timisoara, RomaniaResearch network
- Collaborators
- Carol Davila University of Medicine and Pharmacy, Grigore T. Popa University of Medicine and Pharmacy, Bucharest Emergency Hospital
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute cholangitis | – | Procedure: ERCPPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital with acute cholangitis undergoing ERCP as part of routine medical care.
Key inclusion criteria (4 listed)
- Patients with acute cholangitis
- Ability to provide an informed consent
- Age over 18 years
- Any gender
Key exclusion criteria (6 listed)
- Age under 18
- Pregnancy
- Post-ERCP perforation
- The patient's decision to abstain from study enrollment
- Patients unable to express informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPERCP will serve as the exclusive therapeutic modality, aided by a therapeutic duodenoscope to access the common bile duct using a guidewire. | Procedure or surgery | Patients with acute cholangitis |
Primary outcome
Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile
Time frame: 2 years
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.
3 secondary outcomes
Isolated bacteria and the etiology of obstructive biliary disease
Time frame: 2 years
Multidrug-Resistance (MDR)
Time frame: 2 years
ERCP naive patients vs. patients with a history of ERCP
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan Miutescu, MD,PhD principal investigator
Emergency County Hospital Pius Brinzeu; Timisoara, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangitis Acute and Biliary Tract Diseases, run by Emergency County Hospital Pius Brinzeu; Timisoara, Romania at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.