Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
Public ClinicalTrials.gov record NCT05303662. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05303662
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,244 participants
Conditions and interventions
Interventions
- 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 Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2022
- Primary completion
- Dec 29, 2024
- Completion
- Dec 29, 2024
- Last update posted
- Aug 7, 2025
2022 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05303662, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05303662 live on ClinicalTrials.gov.