Pseudomonas AeruginosaSAMPANNCT05282082
Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.
An observational study of Pseudomonas Aeruginosa and Colonization, Asymptomatic, run by Erasmus Medical Center at 3 sites in 3 countries.
Trial 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'. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudomonas Aeruginosa, Colonization, Asymptomatic, Nosocomial Infection
- How many people
- 2,105 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All healthy individuals (i.e., not hospitalized) aged 18 years or older and 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;
Who cannot join
- No signed consent sheet.
- Cystic fibrosis patients
- No signed consent sheet.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: 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.
- Medical subject headings
- Pseudomonas Infections, Asymptomatic Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2022/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pseudomonas AeruginosaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Juliëtte Severin, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282082
- Sponsor's protocol ID
- 5025
- Acronym
- SAMPAN
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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 Apr;170:25-33. doi: 10.1016/j.jhin.2026.01.003. Epub 2026 Jan 23.
PubMed 41581609Shahab 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.
PubMed 39787647van 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.
PubMed 39858379van 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.
PubMed 40691185
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.
- ClinicalTrials.gov ID
- NCT05282082
- Acronym / sponsor ID
- SAMPAN / 5025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,105 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- All healthy individuals (i.e., not hospitalized) aged 18 years or older and 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;
Key exclusion criteria (3 listed)
- No signed consent sheet.
- Cystic fibrosis patients
- No signed consent sheet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- BackgroundShahab 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: PubMed 41581609van 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 Apr;170:25-33. doi: 10.1016/j.jhin.2026.01.003. Epub 2026 Jan 23.
- Background: PubMed 39787647Shahab 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.
- Background: PubMed 39858379van 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.
- Results publication: PubMed 40691185van 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Pseudomonas Aeruginosa
RecruitingPhase 4
CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients
Severe Infection
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Active, not recruitingPhase 1
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
Bronchiectasis With Pseudomonas Aeruginosa Colonization
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
Bronchiectasis With Pseudomonas Aeruginosa Colonization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomonas Aeruginosa and Colonization, Asymptomatic, run by Erasmus Medical Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282082, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.