Status:
COMPLETED
AMR-DetecTool for the Diagnostic of MDR Bacterial Infections
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
EIT Health
NG Biotech
Conditions:
Bacterial Sensitivity Tests
Antimicrobial Drug Resistance
Eligibility:
All Genders
18+ years
Brief Summary
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. The failure to stop the spread of antimicrobial resi...
Detailed Description
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. Among these, the increasing rate of infections cause...
Eligibility Criteria
Inclusion
- Patient ≥ 18 years-old
- Informed patient and non-opposition received
- Patients matching with at least one of the following situations:
- With a positive blood culture by Gram-staining. Germ must be identified as a Gram-negative bacteria or a Gram-positive cocci in chain (with a special focus on known Vancomycin-Resistant Enterococci (VRE) carrier)
- With an urinary tract infection \>104 leukocytes and positive for bacteria (Gram stain or cytometry)
- High-risk (HR) patient for carbapenemase-producing Enterobacterales (CPE) carriage (repatriated patients, tourist returning from endemic country, patients coming from an endemic hospital (same country), contact patient, former carrier, and local HR patients (Long-Term Care Facility (LTCF), etc…)) who have been sampled a rectal swab for routine testing
- With a bronchoalveolar lavage (BAL) or tracheal aspirate (TA) sample and diagnosed as carrier of any of the targeted resistance genes (10-35% chance to develop a Ventilator-associated pneumonia (VAP) with the MDR bacteria)
Exclusion
- Patient participation refusal
- Patient subject to judicial protection measure, under tutorship or curatorship
- Patient not-speaking the language spoken in the country of inclusion and without accompanying translator
- Any different sample from the above 4 mentioned one Pregnant women are not excluded to this non-interventional study, as the study does not result in any change in the standard care received by the participant.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 12 2023
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT05378217
Start Date
July 18 2022
End Date
January 12 2023
Last Update
February 6 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Bicêtre hospital
Le Kremlin-Bicêtre, France, 94275
2
Semmelweis University
Budapest, Hungary, 1428 P .O. box 2
3
Hospital Clínic School of Medicine, University of Barcelona
Barcelona, Spain, 08036