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Completed

NCT Number: NCT05282082

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Cipto Mangunkusumo General Hospital, Jakarta, Indonesia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: 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.

    Time frame: 2022/2024

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SAMPAN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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