CompletedNot Applicable

Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Indonesia, Italy, Netherlands2,105 participantsStarted 2022-03-01

Plain-language summary

Pseudomonas aeruginosa causes severe infections in hospitalized patients. The worldwide emergence of carbapenem-resistant P. aeruginosa (CRPA) makes infections by these pathogens almost untreatable. The World Health Organization now ranks CRPA 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 CRPA. The aim of this project is to develop a globally-applicable smart surveillance strategy to guide action against the spread of CRPA. Since P. aeruginosa prefers moist niches, we will focus on the human-water interface. First, highly-sensitive methods to detect CRPA in specific environmental and human niches will be developed. Subsequently, CRPA will be collected in three study sites with increasing prevalences of CRPA, increasingly warmer climates, and different water situations: Rotterdam (The Netherlands), Rome (Italy), Jakarta (Indonesia). CRPA 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 CRPA from different sources and identify transmission routes. Our project will provide insight into the relative contribution of the different potential reservoirs of CRPA to its spread in different settings which will be used for the development of a globally-applicable surveillance strategy for CRPA to guide preventive actions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria healthy individuals: * All healthy individuals (i.e., not hospitalized) aged 18 years or older and 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of CRPA carriage in healthy individuals and newly hospitalized patients, CRPA prevalence in wet hospital environments, CRPA concentrations in aquatic environments, and the frequency and transmission likelihood within epidemiological clusters

Timeframe: 2022/2024

Trial details

NCT IDNCT05282082

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Pseudomonas Aeruginosa trials