Nosocomial Infection Clinical Trial
— SAMPANOfficial title:
A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.
NCT number | NCT05282082 |
Other study ID # | 5025 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | March 1, 2024 |
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | March 1, 2024 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Dr Cipto Mangunkusumo General Hospital | Jakarta | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | |
Netherlands | Erasmus Medical Center | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Dr Cipto Mangunkusumo General Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Indonesia, Italy, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Risk factors for carriage of CR-PA in healthy persons and patients. | 2023/2024 |
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