Curetis has started an additional prospective, multicenter trial of its marketed Unyver P50 Pneumonia Application to demonstrate its clinical and health economic value.
The CE performance evaluation completed last year demonstrated 81% sensitivity at 99% specificity for detecting pneumonia-causing pathogens. Following the market launch in April 2012, Curetis in 2013 presented data from more than 1,000 patient samples showing overall sensitivity of its pathogen panel of 80.6% at a specificity of 96%.
The study aims to establish real-world data on the health economic impact of fast, patient-near molecular testing and subsequent therapy adjustments. It will be conducted in five European centers and will involve several hundred critically ill patients with pneumonia requiring mechanical ventilation.
The study is designed to first evaluate the current pneumonia treatment and clinical outcome situation by detailed chart reviews comparing patients having received initial adequate, respectively inadequate treatment. Data will be used to fine tune endpoints for the interventional, randomized second part of the study, which aims to investigate the potential clinical and economic benefit of the Unyvero system. Parameters analyzed will include type of antibiotic regimen and costs and length of stay in the ICU.
Participating clinicians are intensive care, pulmonology and microbiology specialists Manfred Quintel from University of Goettingen, Tobias Welte from MHH University Clinic Hanover, Philippe Eggimann and Gilbert Greub from CHUV University Hospital of Lausanne, Mathias Pletz from Jena University and Antoni Torres from University Hospital Clinic Barcelona.
“A substantial number of medical studies demonstrate that initial inadequate empirical antibiotics treatment in pneumonia prolongs hospital stays, adds more than $6,400 in costs per patient and greatly increases mortality,” said Oliver Schacht, chief executive officer of Curetis. “This suggests that early diagnosis can be very beneficial for patients and clinics.”