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