Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

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

• Registration Number: NCT05282082
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-01
• Primary Completion: 2023-02-28
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Risk factors for carriage of CR-PA in healthy persons and patients.	2023/2024

Trial Locations

Locations (3)

Dr Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta, Indonesia

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy