Community Research and Development Information Service - CORDIS

H2020

FAST-bact Report Summary

Project ID: 730713

Periodic Reporting for period 1 - FAST-bact (A novel fast test for antibiotic susceptibility testing for Gram positive and Gram negative bacteria)

Reporting period: 2016-12-01 to 2017-11-30

Summary of the context and overall objectives of the project

The FAST-bact project is dealing with a current a pressing topic such as antimicrobial resistance that “threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria” according to WHO. The WHO’s “Antimicrobial resistance: global report on surveillance (2014)” makes clear that resistance to common bacteria has reached alarming levels in many parts of the world and that in some settings, few, if any, of the available treatments options remain effective for common infections. The main problem we address is that there is increasing emergence of resistance to antibiotics which has led to less effective treatment of common bacterial infections.

Current methods for identification and establishing the susceptible/resistance phenotype of Gram + and Gram – bacteria have a turnaround time of at least 48 hours. In addition, most current methods can only be used on pure cultures, and hence some additional 12h required time for isolation and pre-culture before actual antibiotic susceptibility testing (AST). Studies show that inadequate antibiotic treatment is one of the established causes for drug-resistant bacterial strains.

Therefore, there is an urgent need for a Fast and accurate AST method. The novel test delivers ultra-rapid results (within 2h from a Positive Blood Culture) when compared to the current state-of-the art AST methods that have a turnaround time of at least 48 hours. The availability of the FAST-bact tests will directly impact the treatment of all patients contracting bacterial infections each year, and specifically in efficient, early identification and early specific treatment of the 400.000 patients in Europe who each year contract a multiresistant bacterial infection. By providing faster results on the antibiotic susceptibility pattern of the pathogen, the FAST-bact tests will improve treatment, contribute to lowering mortality and morbidity and in the process, improving quality of life for patients.

The project will aim to introduce the FAST-bact tests as product to the market, accompanied by a software package. The consortium aims for the clinical validation of the tests, and envision it possible to produce the tests on a large-scale and regulatory compliant process addressing future IVD-guidelines that we believe will be beeing implemented in Europe at the end of the project

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

For the first year the work of the Partners focused largely on activities enabling and initiating clinical validation of the kits.
In order to be able to validate kits clinically, development had to be finalized for a range of antibiotic drugs; earliest experiments during this period were to measure FAST-bact kit performance and performe further analytical validation on retrospective patient blood samples. After successful analytical method validation the technology transfer from consortium leader FASTinov to industrial partner Euroclone was initiated. To be able to run the clinical validation, a small-scale production process was to be adapted and implemented. The optimal method for conservation of the FAST-bact kits was chosen to be lyophilization after revision by the industrial partners of the previous work done at FASTinov. Currently this conservation technique is being optimized even further. A major result achieved here is the successful implementation of production processes based on the technology transfer performed already in March 2017.

Additionally, to realize the good clinical practice of the clinical validation study the Consortium worked towards setting up an efficient structure to support the clinical validation study. It did so by investigating and assessing regulatory aspects according to ISO/NP 20916 Standard on Clinical performance studies for in vitro diagnostic devices (IVDs) using specimens from human subjects. Activities included:
• Study design and protocol development;
• Ethical approval of performing the clinical validation study;
• Site preparation by training responsible staff;
• Implementation of GCP procedures and documents at manufacturer/study sites

These activities resulted in two major outcomes:
• Completed study design;
• Ethical approval at Hospital Ramon y Cájal & Centro Hospitalar São João.

In line with this development project partners were trained and instructed by a regulatory expert to set-up a fail-proof QA system. The QA-requirements that have been implemented at FASTinov and µRoboptics are in line with ruling legislation for in vitro diagnostic tools.

Towards clinical validation, the software package for data analysis of FAST-bact kits and routine methods is under development. First steps towards data analysis software have been undertaken. A strategy has been developed to create an application that could be used by clients during the commercialization phase. a stand-alone application, an integrated application and web application. Two of these methods have been developed. Besides these developments the current version of the software has been significantly improved by enhancing the algorithms ability to recognize susceptibility and resistance profiles. Besides this client-based development, software improvements have resulted in improved internal research procedures and data export as well.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This project’s objective is the successful commercialization of FAST-bact kits. With the introduction of these kits, with support of the developed large scale production, clinically validated and regulatory compliant, we expect to serve important healthcare issues and fulfil needs of society regarding antibiotic resistance. The kits that are under development are able to produce a reliable antibiotic susceptibility test within 2h after a Positive Blood Culture. Compared to other methods this will lead to a quickly produced report on the susceptibility phenotype of the bacterial pathogen that infected a specific patient. This will allow target therapy with much more narrow spectrum, for example: in case of resistant phenotypes it will allow a more aggressive therapy in useful time. On the other hand it will reduce the common empirical clinical practice of treatment of patients with wide-spectrum antibiotics, in order to try to control/reduce the severity of the infection until results of the AST are in from the clinical lab, and will provide a much more specific way of treating the patient immediately but also efficiently (using the appropriate antibiotic for the infectious pathogen). The benefits of a quick report will not only impact the patient treatment and health but also contribute to the safety of the public health system and stakeholders by allowing a timely isolation of those patients infected with AMR strains, avoiding the spread of the AMR pathogen. Economically, the innovation will contribute to reduce hospital stay by approximately 17% and contribute to reduce costs by approximately 22%.

The innovation we present in this project has received support of important industrial players as well as international scientific organizations of clinicians, laboratories and pharmaceutical companies active in antimicrobial drug development. With this support we highlight the relevance of our products to combat AMR, reducing the empirical clinical use of antibiotics contributing to efficient implementation of stewardship programs and contribute to the healthcare goals for global healthcare.

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