Tag: EU clinical trial
Company News: Curetis Completes Enrollment for its EU Trial As Planned
– Prospective multi-center trial enrolls 800 patient samples in 7 months-
Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.
The trial will compare the performance of the Unyvero™ P50 Pneumonia Cartridge with conventional microbiology culture, the current standard of care. Primary endpoint will be clinical sensitivity and specificity for the identification of 17 pathogens covered by the Unyvero™ P50 panel. Secondary endpoints include time to result and correlation of resistance marker detection with phenotypic antibiograms. Curetis will conduct systematic discrepant results resolution by PCR and sequencing to confirm the clinical truth in samples where Unyvero results differ from microbiology culture.
The study complements the previously completed CE performance evaluation study, in which the Unyvero P50 Cartridge identified a significant number of additional pathogens not detected by microbiology culture. These findings were confirmed by PCR analysis.