Examining the presence of drug-resistant bacteria in patients undergoing ERCP across four countries
Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries
Erasmus Medical Center · NCT05303662
This study is testing how common drug-resistant bacteria are in patients getting a certain procedure called ERCP to see if using disposable tools could help prevent infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1372 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 4 sites (Pittsburgh, Pennsylvania and 3 other locations) |
| Trial ID | NCT05303662 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prevalence of multidrug-resistant microorganisms in patients scheduled for Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. It involves testing for these organisms through rectal and oral/nasal swabs, as well as duodenal aspirates. The study aims to assess the need for using disposable endoscopes in patients carrying these resistant bacteria to prevent potential infections linked to contaminated reusable duodenoscopes. The findings could inform future guidelines on endoscope usage in high-risk patients.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled to undergo an ERCP procedure who can provide informed consent.
Not a fit: Patients not undergoing ERCP procedures or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infection control practices during ERCP procedures, enhancing patient safety.
How similar studies have performed: While the approach of testing for multidrug-resistant organisms is established, the specific focus on ERCP procedures and the use of disposable endoscopes in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * In case the inclusion criteria were not met
Where this trial is running
Pittsburgh, Pennsylvania and 3 other locations
- UPMC — Pittsburgh, Pennsylvania, United States (RECRUITING)
- AIG hospitals — Hyderabad, Telangana, India (RECRUITING)
- Humanitas research hospital — Milano, Lombardy, Italy (RECRUITING)
- Erasmus MC — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: M. J. Bruno, Professor — Erasmus Medical Center
- Study coordinator: K. van der Ploeg, MD
- Email: k.ploeg@erasmusmc.nl
- Phone: +31650032327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Drug Resistance, Multiple, Bacterial, Cholangiopancreatography, Endoscopic Retrograde, Equipment Contamination, Duodenoscope associated infection