Drug Resistance, Multiple, BacterialPREVENTNCT05303662
Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
An observational study of Drug Resistance, Multiple, Bacterial and Cholangiopancreatography, Endoscopic Retrograde, run by Marco J. Bruno at 4 sites in 4 countries.
Trial summary
The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistance, Multiple, Bacterial, Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs, MDRO-testing duodenal aspirate and Microbiome through rectal swab
- Type of treatment
- Pill or oral medicine
- How many people
- 1,244 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 31 Jan 2022to 30 Dec 2024
- 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
- Adult, Older adult
Study population: Patients undergoing ERCP procedures irrespective of the indication for that procedure
Who may be able to join
- The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
- The subject is capable to understand the information required to give informed consent
Who cannot join
- In case the inclusion criteria were not met
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries
The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.
- Being tested
- Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs, MDRO-testing duodenal aspirate, Microbiome through rectal swab, Microbiome testing duodenal aspirate
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde, Drug Resistance, Multiple, Bacterial, Equipment Contamination, Duodenoscope associated infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabsDiagnostic test
Pooled throat/nose sample and a rectal sample is taken prior to the ERCP
MDRO-testing duodenal aspirateDiagnostic test
Duodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's
Microbiome through rectal swabDiagnostic test
An rectal swab is collected for microbiome purposes
Microbiome testing duodenal aspirateDiagnostic test
Duodenal aspirate is collected from the duodenum, diluted and undiluted for microbiome analysis
| Study group | Role | What they receive |
|---|---|---|
| ERCP-patients Netherlands | Patients undergoing ERCP in the study site in the Netherlands Receives: Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs; Diagnostic Test: MDRO-testing duodenal aspirate; Diagnostic Test: Microbiome through rectal swab; Diagnostic Test: Microbiome testing duodenal aspirate | |
| ERCP-patients Italy | Patients undergoing ERCP in the study site in Italy Receives: Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs | |
| ERCP-patients United States | Patients undergoing ERCP in the study site in the Netherlands Receives: Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs | |
| ERCP-patients India | Patients undergoing ERCP in the study site in India Receives: Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs; Diagnostic Test: MDRO-testing duodenal aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries
Prevalence (as a percentage) of Methicillin-resistant Staphylococcus aureus (MRSA) in nasal or throat swabs, along with rectal carriage rates of Extended Spectrum Beta-Lactamase (ESBL), Vancomycin-resistant Enterococci (VRE), Carbapenem-resistant Enterobacterales (CRE), Carbapenemase-Producing Pseudomonas aeruginosa (CPP), and resistant Acinetobacter among ERCP patients in India, the Netherlands, Italy, and the United States.
Measured: 1 week
Secondary outcomes (4)
Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum
Prevalence (as a percentage) of duodenal carriage of MRSA, ESBL, VRE, CRE, CPP, and resistant Acinetobacter among ERCP patients in both India and the Netherlands.
Measured: 1 week
Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO
Sequencing data analysis, such as 16S rRNA gene sequencing, will be used to assess the overall composition of the rectal microbiome. This will involve the identification of various bacterial taxa present in the samples and determining their relative proportions. The results will provide information on the broader microbial community composition.
These results will be compared between ERCP patients carrying MDRO and those without MDRO to investigate differences in both specific bacterial species' abundance and overall microbiome composition.
Measured: 1 week
Prevalence of duodenoscope-associated infections and colonizations
Comparison of isolates form duodenoscope cultures with isolates from clinical cultures from patients treated with a contaminated duodenoscope in order to detect transmission.
Measured: 6 months
Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO
Sequencing data analysis, such as 16S rRNA gene sequencing, will be used to assess the overall composition of the duodenal microbiome. This will involve the identification of various bacterial taxa present in the samples and determining their relative proportions. The results will provide information on the broader microbial community composition.
These results will be compared between ERCP patients carrying MDRO and those without MDRO to investigate differences in both specific bacterial species' abundance and overall microbiome composition.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start31 Jan 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug Resistance, Multiple, BacterialStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco J. Bruno
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Marco J. Bruno, Erasmus Medical Center
- Investigators
- M. J. Bruno, Professor, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303662
- Sponsor's protocol ID
- NL79136.078
- Acronym
- PREVENT
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rauwers AW, Voor In 't Holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut. 2018 Sep;67(9):1637-1645. doi: 10.1136/gutjnl-2017-315082. Epub 2018 Apr 10.
PubMed 29636382van der Ploeg K, Vos MC, Rughwani H, Severin JA, Post RAJ, Reddy DN, Veturi SY, Sasikala M, Memon SF, Repici A, Spadaccini M, Colombo M, Andreozzi M, Stevens BA, Das R, Slivka A, Mason-Slingerland BCGC, Bruno MJ. Preprocedural screening for multidrug-resistant organisms in endoscopic retrograde cholangiopancreatography: an international, multicentre, cross-sectional observational study. EClinicalMedicine. 2025 Nov 13;90:103627. doi: 10.1016/j.eclinm.2025.103627. eCollection 2025 Dec.
PubMed 41324017
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries
- ClinicalTrials.gov ID
- NCT05303662
- Acronym / sponsor ID
- PREVENT / NL79136.078
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde, Drug Resistance, Multiple, Bacterial, Equipment Contamination, Duodenoscope associated infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,244 participants (actual)
- Lead sponsor
- Marco J. BrunoUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 31 Mar 2022 (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.
The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ERCP-patients Netherlands | – | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs, Diagnostic Test: MDRO-testing duodenal aspirate, Diagnostic Test: Microbiome through rectal swab, Diagnostic Test: Microbiome testing duodenal aspiratePatients undergoing ERCP in the study site in the Netherlands |
| ERCP-patients Italy | – | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabsPatients undergoing ERCP in the study site in Italy |
| ERCP-patients United States | – | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabsPatients undergoing ERCP in the study site in the Netherlands |
| ERCP-patients India | – | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs, Diagnostic Test: MDRO-testing duodenal aspiratePatients undergoing ERCP in the study site in India |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ERCP procedures irrespective of the indication for that procedure
Key inclusion criteria (2 listed)
- The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
- The subject is capable to understand the information required to give informed consent
Key exclusion criteria (1 listed)
- In case the inclusion criteria were not met
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 |
|---|---|---|
| Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabsPooled throat/nose sample and a rectal sample is taken prior to the ERCP | Diagnostic test | ERCP-patients India, ERCP-patients Italy, ERCP-patients Netherlands, ERCP-patients United States |
| MDRO-testing duodenal aspirateDuodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's | Diagnostic test | ERCP-patients India, ERCP-patients Netherlands |
| Microbiome through rectal swabAn rectal swab is collected for microbiome purposes | Diagnostic test | ERCP-patients Netherlands |
| Microbiome testing duodenal aspirateDuodenal aspirate is collected from the duodenum, diluted and undiluted for microbiome analysis | Diagnostic test | ERCP-patients Netherlands |
Primary outcome
Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries
Time frame: 1 week
Prevalence (as a percentage) of Methicillin-resistant Staphylococcus aureus (MRSA) in nasal or throat swabs, along with rectal carriage rates of Extended Spectrum Beta-Lactamase (ESBL), Vancomycin-resistant Enterococci (VRE), Carbapenem-resistant Enterobacterales (CRE), Carbapenemase-Producing Pseudomonas aeruginosa (CPP), and resistant Acinetobacter among ERCP patients in India, the Netherlands, Italy, and the United States.
4 secondary outcomes
Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum
Time frame: 1 week
Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO
Time frame: 1 week
Prevalence of duodenoscope-associated infections and colonizations
Time frame: 6 months
Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO
Time frame: 1 week
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 8 Aug 2025.
- Background: PubMed 29636382Rauwers AW, Voor In 't Holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut. 2018 Sep;67(9):1637-1645. doi: 10.1136/gutjnl-2017-315082. Epub 2018 Apr 10.
- Derived from this study: PubMed 41324017van der Ploeg K, Vos MC, Rughwani H, Severin JA, Post RAJ, Reddy DN, Veturi SY, Sasikala M, Memon SF, Repici A, Spadaccini M, Colombo M, Andreozzi M, Stevens BA, Das R, Slivka A, Mason-Slingerland BCGC, Bruno MJ. Preprocedural screening for multidrug-resistant organisms in endoscopic retrograde cholangiopancreatography: an international, multicentre, cross-sectional observational study. EClinicalMedicine. 2025 Nov 13;90:103627. doi: 10.1016/j.eclinm.2025.103627. eCollection 2025 Dec.
- Individual participant dataSharing planned: Undecided
Related trials for Drug Resistance, Multiple, Bacterial
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingObservational study
Bioneer Q-RFIA Clinical Evaluation
Tuberculosis, Multidrug-Resistant
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.
M. J. Bruno, Professor principal investigator
Erasmus Medical Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistance, Multiple, Bacterial and Cholangiopancreatography, Endoscopic Retrograde, run by Marco J. Bruno at 4 sites in 4 countries.
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 2 inclusion and 1 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, India, Italy, Netherlands. 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?
Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303662, which also lists 2 linked publications.
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 8 Aug 2025.