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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

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

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  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

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