Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Study Overview
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Brief Summary
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Pseudomonas aeruginosa causes severe infections in hospitalized patients. The worldwide emergence of carbapenem-resistant P. aeruginosa (CR-PA) makes infections by these pathogens almost untreatable. The World Health Organization now ranks CR-PA highest in the list of 'urgent threats'. Information for action to prevent further emergence has to come from insight into sources and transmission routes through smart surveillance. At present, a smart surveillance strategy is not available for CR-PA. The aim of this project is to develop a globally-applicable smart surveillance strategy to guide action against the spread of CR-PA. Since P. aeruginosa prefers moist niches, we will focus on the human-water interface. First, highly-sensitive methods to detect CR-PA in specific environmental and human niches will be developed. Subsequently, CR-PA will be collected in three study sites with increasing prevalences of CR-PA, increasingly warmer climates, and different water situations: Rotterdam (The Netherlands), Rome (Italy), Jakarta (Indonesia). CR-PA will be searched for in a variety of niches in the environment outside and inside the hospital, and in healthy humans and hospitalized patients. Whole genome sequencing will be performed to compare the CR-PA from different sources and identify transmission routes. Our project will provide insight into the relative contribution of the different potential reservoirs of CR-PA to its spread in different settings which will be used for the development of a globally-applicable surveillance strategy for CR-PA to guide preventive actions.

Official Title
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A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Conditions
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Pseudomonas Aeruginosa, Colonization, Asymptomatic, Nosocomial Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria healthy individuals: All healthy individuals living in a high-risk area in Rotterdam, Rome or Jakarta. Exclusion Criteria healthy individuals: No signed consent sheet Inclusion Criteria patients: Must be aged 18 years or older; Should be capable of providing answers to the questions in the questionnaire by himself/herself; Should have a minimum expected length of stay of at least 24 hours; Inclusion only once during the sampling year. Exclusion Criteria patients: Cystic fibrosis patients No signed consent sheet.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at the moment of their admission to the hospital in one of the three cities<br>Swabs will be taken from patients who are willing to participate. | |
| Healthy volunteers living in high-risk areas in one of the three cities.<br>Swabs will be taken from healthy volunteers who are willing to participate. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalences of CR-PA in samples taken from healthy persons and patients at the moment of their admission to the hospital in the three cities. |  | 2023/2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for carriage of CR-PA in healthy persons and patients. |  | 2023/2024 |