Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

NCT05282082 | Completed

• 1 other identifier: 5025
• Study Type: observational
• Target: 2,105
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Pseudomonas Aeruginosa; Nosocomial Infection; Colonization, Asymptomatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All healthy individuals (i.e., not hospitalized) aged 18 years or older and living in a "high-risk area" in Rotterdam, Rome or Jakarta.

You may not qualify if:

• No signed consent sheet.
• 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;
• Cystic fibrosis patients
• No signed consent sheet.

Sponsors & Collaborators

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

Study Sites (3)

Dr Cipto Mangunkusumo General Hospital

Jakarta, Indonesia

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (5)

• 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

  BACKGROUND

• 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.

  PMID: 41581609 BACKGROUND

• 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.

  PMID: 39787647 BACKGROUND

• 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.

  PMID: 39858379 BACKGROUND

• 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.

  PMID: 40691185 RESULT

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

CRPA isolates will be collected and retained.

MeSH Terms

Conditions

Pseudomonas Infections; Asymptomatic Infections; Cross Infection

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Medical coordinator Unit infection prevention

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ID (1); NL (1); IT (1)