Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Erasmus University

Status: Unknown

Conditions: Nosocomial Infection; Colonization, Asymptomatic; Pseudomonas Aeruginosa

Study type: Observational

Funder types: Other

Identifiers

NCT05282082

5025

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

3,000 participants in 2 patient groups

Patients at the moment of their admission to the hospital in one of the three cities

Description:

Swabs will be taken from patients who are willing to participate.

Healthy volunteers living in "high-risk areas" in one of the three cities.

Description:

Swabs will be taken from healthy volunteers who are willing to participate.