A Phase 3 Telavancin Staphylococcus Aureus Bacteremia Trial

Condition(s) targeted: Bacteremia

Intervention: Telavancin (Drug); Vancomycin (Drug); Daptomycin (Drug); Synthetic penicillin (Drug); Cefazolin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Overall contact:
Peter St. Wecker, Phone: 650-808-6000, Email: PStWecker@theravance.com

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 (SA) bacteremia and SA right-sided infective endocarditis (RIE).

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 Including SA Right-sided Infective Endocarditis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical response (success or failure)

Secondary outcome:

Development of new metastatic foci of infection

Clearance of bacteremia

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 years of age or older with at least one blood culture positive for SA within 48

hours before randomization

- At least one of the following signs or symptoms of bacteremia:

- Temperature ≥ 38. 0°C

- WBC count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands)

- Tachycardia (heart rate > 90 bpm)

- Tachypnea (respiratory rate > 20 breaths/min)

- Hypotension (systolic blood pressure < 90 mmHg)

- Signs or symptoms of localized catheter-related infection

- At enrollment, subjects must have either 1) known right-sided infective endocarditis

by Modified Duke's criteria 2)known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of SA infection or 3) at least one risk factor for complicated bacteremia. Exclusion Criteria:

- Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic

for more than 48 hours within 7 days before randomization EXCEPTION: Documented resistance to the prior systemic antibacterial therapy

- Presence of any removable infection source (e. g., intravascular line, abscess) that

will not be removed or debrided within 3 days after randomization

- Presence of prosthetic joint or cardiac device (e. g., implantable cardioverter

defibrillator (ICD), permanent pacemaker, or prosthetic valve or cardiac valve support ring)

- Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria

NOTE: Right-sided infective endocarditis (RIE) is permitted

- Known or suspected osteomyelitis (primary or embolic), or meningitis (primary) NOTE:

Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary infarcts are permitted

Peter St. Wecker, Phone: 650-808-6000, Email: PStWecker@theravance.com

eStudySite, Chula Vista, California 91911, United States; Recruiting
Scott Overcash, MD

Starting date: December 2014
Last updated: March 17, 2015