Evaluating the advantages of the device

Evaluating the advantages of the device over standard techniques. Aspects of the study: speed of the detection, associated costs and new ways of patient pathway management

This project activity is lead by Thierry Naas
Assistance Publique Hôpitaux de Paris, APHP

Expert level summary

During this phase of the project factors such as gender, age, underlying disease, origin (home, long term care facility, repatriated, recent trip abroad, recent antibiotic treatment, ongoing antibiotic treatments), etc. are recorded and a centralised Web-based spreadsheet (eCRF) is created. The end result is a detailed report outlining the key findings for the clinical study of the Carba5, CTX-M-Multi, VanA/B and OXA-Ab tests.

Detailed activity description

Key activities phase 1: Gathering patient information and setting up Web-based spreadsheet

While WP4 is a large scale biological validation of the Carba 5, the CTX-M-Multi, the VANA/B and OXA-Abs on clinical samples, WP5 gathers clinically-relevant information on the patients the samples came from, e.g. gender, age, underlying disease, origin (home, long term care facility, repatriated, recent trip abroad, recent antibiotic treatment, ongoing antibiotic treatments, outcome). The time to get results for the standard routine techniques and the AMR detectool are recorded. The first task is dedicated to the regulatory aspects of the clinical trial, and setting up a web-based eCRF;

Task 2 corresponds to the Carba 5, the CTX-M-Multi evaluation.

Key activities phase 2: Clinical data evaluation

In addition to ongoing activities of phase 1, the other tasks include clinical data associated with the Carba 5 and the CTX-M-Multi evaluation, and clinical data associated with the VanA/B and OXA-Ab evaluation.