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Infectious Diseases

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SLUHN 2016-73

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 Infective Endocarditis

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Physician

    doctor

    Thong Le, MD

    Study Coordinator

    Erin McLane, RN, BSN
    484-526-7825

    Erin.mclane@sluhn.org
  • Synopsis: When treating patients, doctors are finding infections caused by a type of bacteria called a “Gram-positive pathogen.” Infections caused by these types of bacteria may cause serious and life-threatening diseases in both healthy patients and patients who are already sick. A problem with treating infections caused by these bacteria is that some of the bacteria no longer respond to the current treatments. The development of a new drug that would be effective in treating infections caused by these bacteria is important, and would give doctors another drug to use.
    This study will evaluate the experimental use of telavancin for the treatment of S. aureus blood infection.
    The purpose of this study is to:

    • compare telavancin to standard intravenous (IV) antibiotic therapy (such as vancomycin, daptomycin, anti-staphylococcal penicillin, or cefazolin),
    • treat people with S. aureus blood infection, including people with infected right heart valves,
    • evaluate the level of telavancin and yancomycin in the blood in subjects with S. aureus bacteremia including right infective endocarditis,
    • evaluate the frequency of new locations of the infection in your body,
    • evaluate the safety and tolerability of telavancin compared with standard IV therapy.
    • 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
      • 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.
    • 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 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