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 (CRPA) makes infections by these pathogens almost untreatable. The World Health Organization now ranks CRPA 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 CRPA. The aim of this project is to develop a globally-applicable smart surveillance strategy to guide action against the spread of CRPA. Since P. aeruginosa prefers moist niches, we will focus on the human-water interface. First, highly-sensitive methods to detect CRPA in specific environmental and human niches will be developed. Subsequently, CRPA will be collected in three study sites with increasing prevalences of CRPA, increasingly warmer climates, and different water situations: Rotterdam (The Netherlands), Rome (Italy), Jakarta (Indonesia). CRPA 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 CRPA from different sources and identify transmission routes. Our project will provide insight into the relative contribution of the different potential reservoirs of CRPA to its spread in different settings which will be used for the development of a globally-applicable surveillance strategy for CRPA to guide preventive actions.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 2105

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Dr Cipto Mangunkusumo General Hospital
• Italy
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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 CRPA which may affect humans.

Patients will be included within 48 hours of their admission to the hospital (non-critical medical and surgical wards) in one of the three cities. The three participating hospitals are all university hospitals.

Description

Inclusion Criteria healthy individuals:

• All healthy individuals (i.e., not hospitalized) aged 18 years or older and 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
Prevalence of CRPA carriage in healthy individuals and newly hospitalized patients, CRPA prevalence in wet hospital environments, CRPA concentrations in aquatic environments, and the frequency and transmission likelihood within epidemiological clusters	2022/2024

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence of body site-specific CRPA carriage in healthy individuals and newly hospitalized patients, prevalence of clinical CRPA isolates, and prevalence and geographic distribution of carbapenemase genes.	2022/2024

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Shahab et al. Development of a highly-sensitive method to detect the carriage of carbapenem-resistant Pseudomonas aeruginosa in humans. https://doi.org/10.1101/2024.08.27.609846
• van Veen A, Rijfkogel A, Voor In 't Holt AF, Zandijk WHA, Vos MC, Klaassen CHW, Severin JA. Two-round point-prevalence study unveils shared blaVIM-2 integrons and spread of a blaIMP-15-encoding plasmid among carbapenem-resistant non-aeruginosa Pseudomonas species in the wet hospital environment. J Hosp Infect. 2026 Jan 23;170:25-33. doi: 10.1016/j.jhin.2026.01.003. Online ahead of print.
• Shahab SN, van Veen A, Kemper MA, Rijfkogel A, Vos MC, Karuniawati A, Severin JA, Schmitt H; SAMPAN Consortium. Detection methods for carbapenem-resistant Pseudomonas aeruginosa in surface water and wastewater. Sci Total Environ. 2025 Jan 20;961:178086. doi: 10.1016/j.scitotenv.2024.178086. Epub 2025 Jan 8.
• van Veen A, Shahab SN, Rijfkogel A, Voor In 't Holt AF, Klaassen CHW, Vos MC, Saharman YR, Karuniawati A, Zelli S, De Lorenzis D, Menchinelli G, De Angelis G, Sanguinetti M, Kemper M, de Jong AEE, Mohammadi S, Renaud V, Kukavica-Ibrulj I, Potvin M, Nguyen GQ, Gauthier J, Levesque RC, Schmitt H, Severin JA. Sources and Transmission Routes of Carbapenem-Resistant Pseudomonas aeruginosa: Study Design and Methodology of the SAMPAN Study. Antibiotics (Basel). 2025 Jan 15;14(1):94. doi: 10.3390/antibiotics14010094.
• van Veen A, Shahab SN, Rijfkogel A, Vos MC, Saharman YR, Karuniawati A, Zelli S, De Lorenzis D, Menchinelli G, De Angelis G, Sanguinetti M, Voor In 't Holt AF, Severin JA; SAMPAN Consortium. Pseudomonas aeruginosa carriage and associated risk factors in healthy individuals and patients from Rotterdam, Rome, and Jakarta. Sci Rep. 2025 Jul 21;15(1):26392. doi: 10.1038/s41598-025-10175-y.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 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): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Iatrogenic Disease; Asymptomatic Diseases; Pathological Conditions, Signs and Symptoms; 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
• IPD Plan Description: Metadata for human, hospital environment, and water data are available through the data repository DataverseNL (https://doi.org/10.34894/1OFFVG). Raw reads, assembly data and metadata are available on the International Pseudomonas Consortium Database (https://ipcd.ibis.ulaval.ca/). Deidentified individual participant data and data from environmental, including water, sources that underlie the results reported in this Article can be shared with researchers following submission of a methodologically sound proposal, approval by the SAMPAN Project Board, and can only be made available upon signing a Data Transfer Agreement. Proposals should be directed to the corresponding author or the corresponding author's department (projectmanagement.mmiz@erasmusmc.nl).

Drug and device information, study documents

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