A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
Condition: Bacteremia
MeSH terms: Bacteremia
Intervention: Telavancin; Vancomycin; Daptomycin; Synthetic penicillin; Cefazolin
Intervention MeSH terms: Vancomycin; Cefazolin; Penicillins; Daptomycin; Cloxacillin; Oxacillin; Telavancin; Nafcillin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bacteremia; Staphylococcus aureus

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 (SA-RIE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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