Clinical Trial: A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia

Brief Summary: This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (RIE).

Detailed Summary:
Sponsor: Theravance Biopharma Antibiotics, Inc.

Current Primary Outcome: Clinical response (success or failure) [ Time Frame: Up to 8 weeks ]

Clinical response (success or failure) for subjects with uncomplicated bacteremia receiving 2 to 4 weeks of treatment at test of cure (TOC) (38 [+/-2] days after randomization), for subjects with complicated bacteremia receiving 4 to 6 weeks of treatment at test of cure (TOC) (52 [+/-2] days after randomization), and for subjects with endocarditis receiving 6 weeks of treatment at test of cure (TOC) (52 [+/-2] days after randomization)


Original Primary Outcome: Clinical response (success or failure) [ Time Frame: Up to 10 weeks ]

Clinical response (success or failure) at test of cure (TOC) (28 [+/-2] days after end of treatment (EOT)) in the mITT analysis set


Current Secondary Outcome:

  • Development of new metastatic foci of infection [ Time Frame: After Day 8 ]
  • Clearance of bacteremia [ Time Frame: Up to 8 weeks ]
    For subjects with a positive S. aureus blood culture on Day 1, time to all blood cultures negative for S. aureus for two days in succession


Original Secondary Outcome:

  • Development of new metastatic foci of infection [ Time Frame: After Day 8 ]
  • Clearance of bacteremia [ Time Frame: Up to 10 weeks ]
    For subjects with a positive S. aureus blood culture on Day 1, time to all blood cultures negative for S. aureus for two days in succession


Information By: Theravance Biopharma Antibiotics, Inc.

Dates:
Date Received: July 31, 2014
Date Started: December 2014
Date Completion: May 2018
Last Updated: March 8, 2017
Last Verified: March 2017