Observational Study in patients with ExPEC disease following TRUS-PNB
Research type
Research Study
Full title
Prospective Evaluation of the Incidence of Extraintestinal Pathogenic Escherichia coli (ExPEC) Disease, O-seratype Prevalence of ExPEC, ExPEC Case Definition, and Health Outcomes Following Transrectal Ultrasound Guided Prostate Needle Biopsy (TRUS-PNB).
IRAS ID
217015
Contact name
James Green
Contact email
Sponsor organisation
Janssen Research & Development
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Janssen is currently developing ExPEC4V (JNJ-63771860), a 4-valent polysaccharide vaccine candidate for the prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease. This observational study is intended to estimate the incidence of invasive ExPEC disease in patients undergoing TRUS-PNB in order to support the design of the Phase 3 clinical development program by describing the incidence of invasive ExPEC disease in men aged ≥18 years undergoing transrectal ultrasound-guided prostate needle biopsy (TRUS-PNB) in treatment locations representative of the geographic areas in which the Phase 3 clinical trial will be conducted. Additionally, this study will assess the O-serotype distribution or prevalence of infecting E. coli isolates for patients experiencing invasive ExPEC disease following TRUS-PNB to determine O-serotype coverage for the vaccine. This study will also provide data to meet a regulatory request by the Centre for Biologics Evaluation and Research (CBER) to evaluate the Phase 3 clinical case definition for invasive ExPEC disease. Finally, this study will document the health outcomes and costs associated with invasive ExPEC disease and compare these outcomes to a similar population based on clinical characteristics without invasive ExPEC disease. No study drug will be administered in this non-interventional study.
REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/0069
Date of REC Opinion
9 Jan 2017
REC opinion
Favourable Opinion