Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study. (SAMPAN)

A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Nosocomial Infection; Pseudomonas Aeruginosa; Colonization, Asymptomatic

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Juliëtte A Severin, Dr.; Phone Number: +31 10 7033510; Email: j.severin@erasmusmc.nl

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Recruiting
    • Dr Cipto Mangunkusumo General Hospital
    • Contact: Anis Karuniawati, Prof.dr.; Phone Number: +62 213160491; Email: anis.karuniawatimk@ui.ac.id
    • Contact: Selvi N Shahab, MD; Phone Number: +62 85770564594; Email: s.shahab@erasmusmc.nl
• Italy
  • Roma, Italy
    • Not yet recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Maurizio Sanguinetti, Prof.dr.; Phone Number: 06 / 30154964; Email: maurizio.sanguinetti@policlinicogemelli.it
• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Juliëtte A Severin, Dr.; Phone Number: +31 10 70 33510; Email: j.severin@erasmusmc.nl
      • Contact: Anneloes van Veen, MSc; Phone Number: +31 10 7037489; Email: a.vanveen@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Risk factors for carriage of CR-PA in healthy persons and patients.	2023/2024

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Iatrogenic Disease; Asymptomatic Diseases; Cross Infection; Pseudomonas Infections; Asymptomatic Infections
• Other Study ID Numbers: 5025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No