Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Nosocomial Infection Clinical Trial

— SAMPAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282082
• Other study ID #: 5025
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2022
• Source: Erasmus Medical Center
• Contact: Juliëtte A Severin, Dr.
• Phone: +31 10 7033510
• Email: j.severin[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 1, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asymptomatic Infections
• Cross Infection
• Nosocomial Infection
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Locations

Country	Name	City	State
Indonesia	Dr Cipto Mangunkusumo General Hospital	Jakarta
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Dr Cipto Mangunkusumo General Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Countries where clinical trial is conducted

Indonesia,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk factors for carriage of CR-PA in healthy persons and patients.		2023/2024