AST and antimicrobial combination testing
€3.6 million for clinical validation of a new antimicrobial combination testing method
The BADGER Project
Bacterial Analysis and Diagnostics through Growth and Energy-release in Real-time
The BADGER project will validate calScreener™ as a diagnostic device for the early, correct and timely diagnosis of heteroresistant and extensively resistant bacterial infections, and also as the first method that can be clinically used for antimicrobial combination testing.
Every hour without correct treatment for sepsis patients drastically reduces the chances of surviving. We aim to change this with a robust, rapid and accurate diagnosis. The testing will focus on the most common gram-negative sepsis causing bacteria:
Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii
The project runs over 28 months with a consortium of internationally recognized academic and clinical key opinion leaders in Antimicrobial Susceptibility Testing in Europe.
AST and antimicrobial combination testing
Growing concerns over antimicrobial-resistance as one of the greatest risks globally to human health have been raised by the world organizations. As a result, tackling antimicrobial resistance by developing innovative diagnostic tests and prescribing correct combination treatment have become a high priority worldwide.
Symcel aims to validate calScreener™ for antimicrobial susceptibility testing and antimicrobial combination testing, and with that will play a significant role in addressing three of the five key objectives of the Global Action Plan on antimicrobial resistance presented by the WHO: strengthening surveillance, reducing the incidence of infection and optimizing the use of antimicrobial medicines.
We have a two-fold focus: antimicrobial susceptibility testing, for determining both Minimal Inhibitory Concentration (MIC) of susceptible Sepsis-causing bacteria and thereby cutting several hours to faster treatment; and antimicrobial combination testing, for determining susceptibility for antibiotics given in combination against extensively resistant bacteria. Therefore, Symcel will establish calScreener™ as the gold standard for antimicrobial combination testing, as well as, a surrogate method to the current standard method for MIC determination.
Clinical Studies in BADGER
The scientific validation of calScreener™ for antimicrobial susceptibility testing (AST) will be performed based on three clinical studies:
Clinical study No. 1
Initially the project will establish in the calScreener™ the correct analytical parameters for the MIC of well characterized susceptible and resistant reference strains. Secondly, analysis will be conducted to validate calScreener™ on stored patient isolates with known antimicrobial susceptibility.
Clinical study No. 2
The second and retrospective study, will focus on conducting susceptibility testing of multi drug-resistant gram-negative bacilli from stored patient isolates, using a mono and combination therapy (synergy testing). The resulting combination therapy and synergy defined in the calScreener™ will be validated in vivo in an animal model, and with international reference methodology (ISO standards) in case of single antimicrobials. The testing of combination treatment is the key objective of the BADGER project as it will establish calScreener as the best clinical method for antimicrobial combination testing. The ability to accurately determine the desired treatment combination will lead to better cures and help combat antibiotic resistance spread.
Clinical study No. 3
The third study will be a prospective observational study, demonstrating that calorimetry can be used as a gold standard method for both antimicrobial combination testing and antimicrobial susceptibility testing, using fresh patient samples with confirmed bloodstream infection.
Key European Partners
Dr. Giske is the head Physician of Bacteriology, Mycobacteriology and Mycology and Head of the Division of Clinical Microbiology at Karolinska University Hospital and Institute, respectively, where he also leads a research group.
He is Chairman of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and serves on the advisory board of ECDC’s European resistance surveillance as a leader of the microbiological workpackage for the WHO surveillance project CAESAR (Eastern Europe and Central Asia).
The most important research activities in his research group pertain to deep-characterization of molecular mechanisms of resistance, virulence, and molecular epidemiology of extensively drug-resistant enteric bacilli.
In the BADGER project, he will be the Principal Investigator of the Clinical Studies.
Dr. Cantón Moreno is the head of the Microbiology Unit at the Hospital Universitario Ramón y Cajal and associated professor of the Clinical Microbiology at the Universidad Complutense de Madrid, Spain. He is currently Clinical Data Coordinator, former Chairman of European Committee on Antimicrobial Susceptibility Testing (EUCAST) and member of the executive committee of the Spanish Antibiogram Committee (COENSANT).
Dr. Cantón is also member of the editorial board of Microbial Drug Resistant, Drug Resistance Updates and Enfermedades Infecciosas y Microbiología Clínica journals and the editor of the Clinical Microbiology Procedures of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).
Its clinical and research work is focussed on antimicrobial resistance mechanisms, antimicrobial susceptibility testing, respiratory tract infections (mainly in cystic fibrosis patients), and interplay of clonal epidemiology and resistance.
He has published more than 400 articles in medical journals (H-index of 55 in 2016), 45 chapters in teaching books and has presented more than 500 abstracts at international and national congress and has given more than 370 conferences.
Dr. Rossolini is the Director of the Clinical Microbiology Unit at Florence Careggi University Hospital and is a Full Professor of Microbiology and Clinical Microbiology at the University of Florence.
He has previously served as Director of the Clinical Microbiology Unit at Siena University Hospital, Chairman of the Department of Molecular Biology and Dean of the Medical Faculty at the University of Siena.
He has served as Editor for Antimicrobial Agents and Chemotherapy for 10 years (2004-2014) and is a member of the Editorial Board of several international journals focused on Clinical Microbiology and Antimicrobial Chemotherapy.
His main research interests are in the field of antimicrobial agents and microbial drug resistance.He is the author of more than 380 scientific articles listed in the PubMed database (Scopus, >13000 citations; h-index, 63) and inventor in 10 patent applications related to diagnostics, antimicrobial agents or other biotechnological products.
Niels Frimodt-Møller is the Head of the Department of Clinical Microbiology at Rigshospitalet and former associated professor in the Department of Clinical Microbiology at Hvidovre Hospital. He has also been head of Antibiotic Research, Department of antibiotic resistance and hospital hygiene at Statens Serum Instituta and Head of Department of Clinical Microbiology at Statens Serum Institut and Bispebjerg Hospital.
Niels has taken part in a substantial number of scientific projects during his professional career including projects funded under the 5th, 6th and 7th Framework Programmes. He was the Principle Investigator of the ADMER project on the prudent use of antibiotics in Ghana, the results of which are currently being implemented in a national antibiotic policy by the Ghanaian Ministry of Health. He was also the Principle Investigator of DanCARD, a research collaboration funded by the Danish National Strategic Research Council on procurement of new antibiotics and better use of antibiotics (2010-2016).
His research activities have focused on antibiotic activity in vitro and in vivo, antibiotic resistance, urinary tract infections, E.coli virulence and infection, S. aureus bacteraemia and endocarditis, bacterial genetics in virulence, resistance, diagnosis and epidemiology.
Niels has published in over 300 peer reviewed journals, and is the co-editor or author of 23 books or chapters.
Professor Annelies Verbon is the chair of the department of Medical Microbiology and Infectious Diseases at Erasmus Medical Center and former chair of the the division of Infectious Diseases in the Maastricht University Medical Center.
Her reseach and patient care specialities focus on Staphylococcus aureus carriage and infections, meticillin resistant S. aureus, prosthesis related infection and HIV adherence in migrants, adverse effects of cART and HIV eradication studies.
In total she has published over 115 peer reviewed papers and acted as (co-)promotor for several PhD theses. She is president of the Dutch Association of Internists specialised in Infectious Diseases and participates in several national guideline committees.
Dr. Willem van Wamel is head of the Staphylococcus-group at the Erasmus MC and Assistant Professor of the Medical Microbiology and Infectious Diseases at Erasmus Medical Center, where he is also core lecturer Research Master of Infection & Immunity and supervisor of several PhD students and technicians.
He has worked at the Institute for Microbiology, Infectious Diseases and inflammation, UMC-Utrecht, also at Dartmouth Medical School, Hanover, and in the Laboratory of Bacterial Pathogenesis & Immunology, at The Rockefeller University, New York, where he served as a scientific tutor.
His research is mainly focus in the pathogenesis of Staphylococcus aureus and the natural humoral response direct against it, the development of new antimicrobial therapies and biofilms.
Dr. Steen Carlsson is research director at the Swedish institute of Health Economics (IHE) and her research and consultancy include economic evaluation of medical technologies and health interventions, and statistical analyses of health registry data.
She has more than 25 years of experience of real-world data analyses, economic evaluation and health measurement and more than 50 original articles in medical and economics journals. She is appointed health economic expert for authorities, organizations and companies including Nordic Health Economist’s Study Group (2016 – present) and the Swedish Society for Health Economics (2011-present).
Katarina is associate professor of health economics at Lund University and has co- supervised over 10 PhDs and supervised 2 post-doctoral fellows.
Jonas Hjelmgren is research director at the Swedish institute of Health Economics (IHE) and has many years of health economic experience from consultancy and the pharmaceutical industry.
Jonas worked at IHE 2001-2007 and developed and adapted economic models and conducted preference and willingness to pay studies.
The work in the pharmaceutical industry has primarily focused on optimizing the use of health economics models in connection with reimbursement applications of drugs all over the world.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 784514.