1 / 11

Catheter-Related Blood Stream Infections A Phase 2 Randomized, Controlled Trial of Dalbavancin vs. Vancomycin

Catheter-Related Blood Stream Infections A Phase 2 Randomized, Controlled Trial of Dalbavancin vs. Vancomycin. Tim Henkel, MD, PhD Executive VP and Chief Medical Officer Vicuron Pharmaceuticals. Study Design . Phase 2 Randomized, controlled, open label

posy
Download Presentation

Catheter-Related Blood Stream Infections A Phase 2 Randomized, Controlled Trial of Dalbavancin vs. Vancomycin

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Catheter-Related Blood Stream InfectionsA Phase 2 Randomized, Controlled Trial of Dalbavancin vs. Vancomycin Tim Henkel, MD, PhD Executive VP and Chief Medical Officer Vicuron Pharmaceuticals

  2. Study Design • Phase 2 • Randomized, controlled, open label • Clinical and microbiological entry criteria • Gram-positive CR-BSI • Primary endpoint—global response at FU • Sample size planned ~60/group • Descriptive statistics with 95% CIs

  3. Inclusion criteria • Documented Gram-positive bacteremia or • Empiric enrollment allowed pending cultures if 2 signs • core temperature 38.0ºC or 36.0ºC • WBC count 12,000, 4,000 or 10% bands • tachycardia • tachypnea • transient hypotension

  4. Exclusion criteria • 24 hrs of prior antibiotic therapy (Gram +) • Alternate focus of infection identified • Recent S. aureus bacteremia from a source other than a CVC • 2 weeks antibiotic therapy anticipated • Creatinine clearance 50 ml/min, • Neutropenia (ANC 100/mm3 for 72 hours) • Use of chronic immunosuppressive drugs • Documented resistance to either study drug

  5. Microbiological Methods • Catheter cultures • Time to positivity of catheter vs. peripheral cultures • Insertion site exudate cultures • Identity of paired cultures confirmed by • Antibiograms • PFGE

  6. Outcome Definitions • Clinical: • Success: improvement in signs/ symptoms and no additional therapy required • Failure: persistence of signs and symptoms and additional therapy required. • Microbiological: • success • Failure

  7. Categories of Infection • Definite CR-BSI: one of the following: • 1 positive peripheral blood culture, plus one of: • positive semi quantitative (catheter tip, 15 CFU) • quantitative (lumen wash, 102 CFU/mL) catheter culture • positive hub or tunnel exudate culture • 5-fold increase in CFU/mL of identical pathogen from central vs. peripheral blood culture • 2 hour longer time to positivity for the peripheral culture relative to the central culture

  8. Categories of Infection • Probable CR-BSI: • S. aureus: 1 positive peripheral blood culture(in absence of other source of infection) • All other organisms: 2 blood cultures positive for identical species, at least 1 peripheral

  9. Phase 2 CRBSI – Enrollment • 34 centers in North America • Enrollment period of 17 months • 2639 patients screened • 75 patients enrolled

  10. Reasons for Screening Failures

  11. Conclusions • A common disease, but challenging to study • Heterogeneous population • Inclusion/Exclusion criteria may result in population not representative of true disease spectrum • Microbiological methods not standard of care • No approved comparator • Phase 3 study with current CRBSI design not feasible • Alternate approaches to bacteremia indications and study design needed

More Related