Clinical trial NCT05282082: Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.
Official title: A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudomonas Aeruginosa
Colonization, Asymptomatic
Nosocomial Infection
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2022-03-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers are individuals living in "high-risk areas" in one of the three cities. "High-risk areas" are areas that we expect to have a high prevalence of CR-PA which may affect humans.

Patients will be included at the moment of their admission to the hospital in one of the three cities. The three participating hospitals are all university hospitals.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 2023/2024
Secondary outcomes:
measure: Risk factors for carriage of CR-PA in healthy persons and patients.
timeFrame: 2023/2024
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dr Cipto Mangunkusumo General Hospital
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
References: