Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

NCT ID: NCT05282082

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pseudomonas Aeruginosa Colonization, Asymptomatic Nosocomial Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All healthy individuals living in a "high-risk area" in Rotterdam, Rome or Jakarta.


* 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

* No signed consent sheet


* Cystic fibrosis patients
* No signed consent sheet.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Juliëtte Severin

Associate professor, Medical coordinator Unit infection prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr Cipto Mangunkusumo General Hospital

Jakarta, , Indonesia

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status NOT_YET_RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Indonesia Italy Netherlands

Central Contacts

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Juliëtte A Severin, Dr.

Role: CONTACT

+31 10 7033510

Facility Contacts

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Anis Karuniawati, Prof.dr.

Role: primary

+62 213160491

Selvi N Shahab, MD

Role: backup

+62 85770564594

Maurizio Sanguinetti, Prof.dr.

Role: primary

06 / 30154964

Juliëtte A Severin, Dr.

Role: primary

+31 10 70 33510

Anneloes van Veen, MSc

Role: backup

+31 10 7037489

Other Identifiers

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5025

Identifier Type: -

Identifier Source: org_study_id

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