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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05282082
Other study ID # 5025
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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