Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Sponsor
Erasmus Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05282082
Collaborator
Dr Cipto Mangunkusumo General Hospital (Other), Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
3,000
3
24
1000
41.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Feb 28, 2023
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients at the moment of their admission to the hospital in one of the three cities

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

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Risk factors for carriage of CR-PA in healthy persons and patients. [2023/2024]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr Cipto Mangunkusumo General Hospital Jakarta Indonesia
    2 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy
    3 Erasmus Medical Center Rotterdam Zuid-Holland Netherlands 3015 GD

    Sponsors and Collaborators

    • Erasmus Medical Center
    • Dr Cipto Mangunkusumo General Hospital
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juliƫtte Severin, Associate professor, Medical coordinator Unit infection prevention, Erasmus Medical Center
    ClinicalTrials.gov Identifier:
    NCT05282082
    Other Study ID Numbers:
    • 5025
    First Posted:
    Mar 16, 2022
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022