A Phase 3 Telavancin Staphylococcus Aureus Bacteremia Trial
Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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
(SA) bacteremia and SA right-sided infective endocarditis (RIE).
Clinical Details
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 infectionClearance of bacteremia
Eligibility
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
Locations and Contacts
Peter St. Wecker, Phone: 650-808-6000, Email: PStWecker@theravance.com
eStudySite, Chula Vista, California 91911, United States; Recruiting Scott Overcash, MD
Additional Information
Starting date: December 2014
Last updated: March 17, 2015
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