Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries

Study Overview
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Brief Summary
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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.

Official Title
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Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries

Conditions
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Drug Resistance, Multiple, Bacterial, Cholangiopancreatography, Endoscopic Retrograde

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERCP-patients Netherlands<br>Patients undergoing ERCP in the study site in the Netherlands | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs<br>* Pooled throat/nose sample and a rectal sample is taken prior to the ERCP<br>Diagnostic Test: MDRO-testing duodenal aspirate<br>* Duodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's<br>Diagnostic Test: Microbiome through rectal swab<br>* An rectal swab is collected for microbiome purposes<br>Diagnostic Test: Microbiome testing duodenal aspirate<br>* Duodenal aspirate is collected from the duodenum, diluted and undiluted for microbiome analysis<br>|
| ERCP-patients Italy<br>Patients undergoing ERCP in the study site in Italy | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs<br>* Pooled throat/nose sample and a rectal sample is taken prior to the ERCP<br>|
| ERCP-patients United States<br>Patients undergoing ERCP in the study site in the Netherlands | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs<br>* Pooled throat/nose sample and a rectal sample is taken prior to the ERCP<br>|
| ERCP-patients India<br>Patients undergoing ERCP in the study site in India | Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs<br>* Pooled throat/nose sample and a rectal sample is taken prior to the ERCP<br>Diagnostic Test: MDRO-testing duodenal aspirate<br>* Duodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Equipment Contamination, Cholangiopancreatography, Endoscopic Retrograde, Drug Resistance, Multiple, Bacterial, Duodenoscope associated infection