PREVENT: Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
Study Details
Study Description
Brief Summary
The duodenoscopes currently used for ERCP (Endoscopic Retrograde Cholangio - and Pancreaticography) 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ERCP-patients Netherlands Patients undergoing ERCP in the study site in the Netherlands |
Diagnostic Test: MDRO-testing through rectal and oral/nasal swabs
Pooled throat/nose sample and a rectal sample is taken prior to the ERCP
Diagnostic Test: MDRO-testing duodenal aspirate
Duodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's
Diagnostic Test: Microbiome through rectal swab
An rectal swab is collected for microbiome purposes
Diagnostic Test: Microbiome testing duodenal aspirate
Duodenal aspirate is collected from the duodenum, diluted and undiluted for microbiome analysis
|
| ERCP-patients Italy Patients undergoing ERCP in the study site in Italy |
Diagnostic Test: MDRO-testing through rectal and oral/nasal swabs
Pooled throat/nose sample and a rectal sample is taken prior to the ERCP
|
| ERCP-patients United States Patients undergoing ERCP in the study site in the Netherlands |
Diagnostic Test: MDRO-testing through rectal and oral/nasal swabs
Pooled throat/nose sample and a rectal sample is taken prior to the ERCP
|
| ERCP-patients India Patients undergoing ERCP in the study site in India |
Diagnostic Test: MDRO-testing through rectal and oral/nasal swabs
Pooled throat/nose sample and a rectal sample is taken prior to the ERCP
|
Outcome Measures
Primary Outcome Measures
- Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries [1 week]
Carriage of MRSA, ESBL, VRE, CRE, CPP, resistant Acinetobacter
Secondary Outcome Measures
- Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP [1 week]
- Differences in bacterial type, amount, and proportions of the rectal and duodenal microbiomes of patients with MDRO compared to patients without MDRO [1 week]
- Prevalence of duodenoscope-associated infections and colonizations [6 months]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
| 2 | AIG hospitals | Hyderabad | Telangana | India | 500032 |
| 3 | Humanitas research hospital | Milano | Lombardy | Italy | 20089 |
| 4 | Erasmus MC | Rotterdam | Zuid-Holland | Netherlands | 3015GD |
Sponsors and Collaborators
- Marco J. Bruno
- Boston Scientific Corporation
Investigators
- Principal Investigator: M. J. Bruno, Professor, Erasmus MC
Study Documents (Full-Text)
None provided.More Information
Publications
- NL79136.078