Status:
TERMINATED
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Bacteremia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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) ...
Eligibility Criteria
Inclusion
- 18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization
- At least one of the following signs or symptoms of bacteremia:
- Temperature ≥ 38.0°C
- White blood cell (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 S. aureus infection or 3) at least one risk factor for complicated bacteremia.
Exclusion
- Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy
- Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment
- Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator \[ICD\]), permanent pacemaker, 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 or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted
- Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2018
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT02208063
Start Date
December 1 2014
End Date
April 12 2018
Last Update
February 17 2020
Active Locations (1)
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1
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215