NCT05378217

AMR-DetecTool for the Diagnostic of MDR Bacterial Infections

Clinical Evaluation of the Accuracy of AMR-DetecTool for the Diagnostic of Infections With Multi Drug Resistant (MDR) Bacteria

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 167 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 caused by Enterobacteriaceae that produce broad-spectrum β-lactamases (ESBLs) and carbapenemases is a major concern worldwide. Moreover, vancomycin-resistance among Enterococcus faecium isolates is becoming a cause of concern in European countries regardless of the geographical location. This increase is due to several factors: 1. Inappropriate use of antibiotics 2. Too late isolation of the carriers 3. Lack of institutional / hospital level strategies to fight antimicrobial resistance (AMR) 4. High transfer abilities due to plasmid-encoded resistance genes The failure to stop the spread of AMR is due to a lack of fast detection methods and proper strategies. Rapid detection and rapid characterization tests are an urgent need. European One Health Action Plan against AMR (2017) states that novel, rapid and reliable diagnostics are crucial 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 β-lactamases and carbapenemases in clinical samples. It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes. When a clinical sample with infection suspicion is received at the microbiology laboratory, the techniques used to determine which the appropriate antibiotic is needed require the sample to be cultured for 16h-24h. Thanks to the DetecTool the culturing step is avoided as the sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown. will be performed in parallel to routine testing on appropriate material of selected samples. No additional samples need to be requested to the participants.

Conditions

• Bacterial Sensitivity Tests
• Antimicrobial Drug Resistance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AMR LFIA Assay	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

Timeline

• Start date: 2022-07-18
• Primary completion: 2022-12-20
• Completion: 2023-01-12
• First posted: 2022-05-18
• Last updated: 2023-02-06

Locations

3 sites across 3 countries: France, Hungary, Spain