Curetis attaches great importance to validating its products according to international standards. Studies are currently underway in the USA and Europe and additional studies are being prepared to evaluate the medical and economic benefits of rapid multiplex PCR tests on infectious disease following market introduction.

You can find publications on the various studies here.

The following studies are currently underway:

Unyvero Hospitalized Pneumonia (HPN) Application 

  • CFDA clearance for commercialisation in mainland China
  • FLAGSHIP: Fast Multiplex Assay of Gram negative rods for antibiotic Stewardship in Hospitalized Patients. Prospective, block-randomised, controlled, multicentre intervention study in Switzerland.
  • INHALE: Potential of molecular diagnostics for hospital-acquired and ventilator-associated pneumonia in UK critical care

  • VAPERO: Impact of a strategy based on the Unyvero testing system on appropriate and targeted antimicrobial treatment in patients with suspected VAP or HAP requiring mechanical ventilation. Randomized, controlled unblinded trial starting in Lille in Oct 2018
  • APAPI: Impact of a PCR‐based strategy on early discontinuation of antimicrobial treatment in patients with suspected aspiration pneumonia requiring mechanical ventilation. Multicenter (North of France), randomized controlled unblinded trial starting in Dec 2018
  • Evaluation Studies from Hospitals in Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden and UK

Unyvero Implant & Tissue (ITI) Application

  • Prospective, controlled, intervention study of a rapid bacterial multiplex PCR as point of care in the management of acute presentation of native joint infection. Northumbria, UK

  • Service evaluation for the Diagnosis of Bone and Joint Infections. Reading, UK

  • Economic interest for the diagnosis of prosthetic hip or knee infections. Grenoble, France

  • Examination of infections in two-stage hip and knee endoprosthesis changes. Rostock and Murnau, Germany
  • Evaluation Studies of Hospital Customers in Austria, Denmark, France, Germany, Netherlands, Norway, Switzerland and UK

Unyvero Blood Culture (BCU) Application

  • Clinical evaluation for the diagnosis of hospital-acquired bloodstream infection. Paris, France

  • Performance evaluation with polymicrobial infections. Nice, France

Unyvero Intra-Abdominal (IAI) Application

  • Evaluation of patients with proven intra-abdominal infections undergoing abdominal surgery. Bochum, Germany

  • Evaluation of patients with acute infection. Nimes, France

  • PEPPER trial: Personalized Medicine with Pentaglobin® after surgical source control in patients with peritonitis, 12 centers across Germany and Austria

Completed Studies:

The Curetis GmbH has successfully concluded over 50 studies and more than 90 publications with Unyvero, including data from over 4,000 tested patient samples.

Unyvero Hospitalized Pneumonia (HPN) Application

  • FDA 510(k) Application : Prospective, multicentre study with over 2,200 patient samples has been completed and results received FDA clearance

  • CE performance evaluation study with 392 patient samples

  • Prospective multicenter EU study with 822 patient samples

  • Evaluation in intensive care for suspected cases of lower respiratory tract infections, 90 samples. Lyon, France

  • Evaluation in a regional hospital center for diagnosis of ventilator-associated pneumonia, 48 samples. Cahors, France

  • Fast diagnostic of hospital‐acquired pneumonia, 90 samples. Munich, Germany

  • Evaluation of clinical impact and antibiotic stewardship, 442 samples. Beaumont hospital, USA

  • Clinical evaluations (e.g. in Munich, Basel, Kuwait, Chicago and Maastricht)

Unyvero  Blood Culture (BCU) Application

  • Multicenter assessment of the rapid Unyvero Blood Culture molecular assay
    207 blood culture bottles tested, very good overall sensitivity (96.8%) and specificity (99.8%), Unyvero BCU covered 90.5% of the species identified by culture, 95% concordance with conventional culture, large number of resistance genes detected (incl. mecA, aacA4, aac(6’)aph(2’’), vanB, ermA, blaCTX-M), reduced time to results: average saving of 34h compared to full microbiology results
  • Multicenter assessment with 207 samples in Bad Oeynhausen, Hamburg, Vienna

  • BEMIDIA: bedside vs. standard microbiological blood culture diagnostics. Prospective observational, open-label mono-centre study in patients with sepsis or septic shock. Greifswald, Germany

  • Evaluation of pathogen and resistance identification in 50 blood cultures. Essen, Germany

Unyvero Intra-Abdominal (IAI) Application

  • Multicenter performance evaluation in Amiens, Bologna, London and Toulouse with 300 samples

Unyvero Implant & Tissue Infection (ITI) Application

  • CE performance evaluation study with 339 patient samples

  • Performance evaluation in the diagnosis and management of Diabetic foot infections, 87 samples. Nimes, France

  • Detection of the etiological agent in pre-surgical joint aspiration fluid, 33 samples. Paris, France

  • Evaluation in the diagnosis of infected chronic leg ulcers, 40 samples. Paris, France

  • Detection of anaerobes from shoulder surgery, 51 samples. Düsseldorf, Germany

  • Evaluation for the diagnosis of endocarditis, 48 samples. Hannover, Germany

  • Clinical evaluation (for example Berlin, Madrid, Freiburg, Bonn, Nantes)

Unyvero Urinary Tract Infection (UTI) Application

  • Multicenter performance evaluation in Cean, Rennes, Mönchengladbach with 316 samples