AMR-DetecTool for the Diagnostic of MDR Bacterial Infections

NCT05378217 | Completed

• 2 other identifiers: APHP2001002021-A02176-35
• Study Type: observational
• Target: 167
• Locations: 3 countries
• Sites: 3

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 resistance (AMR) is due to a lack of fast detection methods and proper strategies. Novel, rapid and reliable detection and characterization tests are an urgent need for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner. AMR-DetecTool or NG Detectool is a detection system for the direct detection of AMR in clinical samples. The clinical sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown. It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes.

Conditions

Bacterial Sensitivity Tests; Antimicrobial Drug Resistance

Keywords

beta-Lactamase Resistance; Carbapenem-Resistant Enterobacteriaceae; Vancomycin Resistance; Immunoassay

Outcome Measures

Primary Outcomes (1)

• Estimate the diagnostic accuracy of the NG DetecTool device in two populations: population 1 (CTX-M-multi, Carba 5), population 2 (Van A / B, Acinetobacter baumannii-specific oxacillinases (OXA- Ab)).

  Accuracy indices will be for each whole test and for each enzyme: sensibility, specificity, positive and negative predictive values. The reference will be standard technics used in routine (usual cultures and antibiograms). The list of patients with discrepancies between the two tests will be edited for the laboratory to determine the resistance mechanisms of these strains, using polymerase chain reaction (PCR)and/or whole genome sequencing of the bacteria.

  AMR Detectool results will be obtained within 30 minutes after the patient is included in the study, and the results will be compared to those of the standard routine techniques, that usually require 48 hours.

Secondary Outcomes (1)

• Describe a diagnostic algorithm for the use of AMR-lateral flow immunoassay (LFIA), allowing thus a more efficient cost-saving patient-pathway structure in hospitals.

  For the entire study period through study completion, an average of 28 days, without censoring at 28 days if an admission is still ongoing.

Interventions

AMR LFIA Assay DIAGNOSTIC_TEST

AMR LFIA will be performed in parallel to routine testing on appropriate sample types retrieved from routine testing : Blood, urine, BronchoAlveolar Lavage (BAL), Tracheal Aspirate (TA), Rectal swab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with positive bacterial detection and hospitalized in one of the following wards: * Medical ICU * Surgical ICU * Infectious disease unit * Nephrology unit * Urology unit

You may qualify if:

• 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)

You may not qualify if:

• Patient participation refusal
• Patient subject to judicial protection measure, under tutorship or curatorship
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• EIT Health: collaborator
• NG Biotech: collaborator
• Commissariat A L'energie Atomique: collaborator

Study Sites (3)

Bicêtre hospital

Le Kremlin-Bicêtre, 94275, France

Location

Semmelweis University

Budapest, 1428 P .O. box 2, Hungary

Location

Hospital Clínic School of Medicine, University of Barcelona

Barcelona, 08036, Spain

Location

Study Officials

• Thierry NAAS, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: May 18, 2022
• Study Start: July 18, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 12, 2023
• Last Updated: February 6, 2023

Record last verified: 2022-11

Locations

ES (1); HU (1); FR (1)