Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
Condition: Bacteremia
MeSH terms: Bacteremia
Intervention: Daptomycin; Comparator
Intervention description: Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.; Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
Intervention MeSH terms: Daptomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The intent of this study is to describe the safety and efficacy of daptomycin versus standard
      of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by
      Staphylococcus aureus (S. aureus).
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, participants must:

          -  Sign a parental consent form; if appropriate, sign an assent form

          -  Be between 1 and 17 years of age

          -  Have proven or probable bacteremia caused by S. aureus based on the traditional
             culture result, rapid diagnostic test or Gram stain

          -  If female of childbearing potential, must not be pregnant or nursing and take
             appropriate measures to not get pregnant during the study

          -  If male, must take appropriate measures to not get partner pregnant

          -  Able to comply with the protocol requirements

        Exclusion Criteria:

        Participants will not be allowed into the study if they:

          -  Have received a certain amount of antibacterial therapy specific for current
             bacteremia unless it is demonstrated that the organism is resistant to the given
             antibacterial;

          -  Anticipate to require other antibiotics that may be potentially effective against S.
             aureus;

          -  Have shock or hypotension unresponsive to standard therapy;

          -  Have received an investigational product or have participated in an experimental
             procedure within 30 days;

          -  Have an intolerance or hypersensitivity to daptomycin;

          -  Have renal insufficiency;

          -  Have prior history or current evidence of muscle damage (rhabdomyolysis; significant
             CPK elevation);

          -  Have history of clinically significant muscular disease, nervous system or seizure
             disorder, including unexplained muscular weakness, history of peripheral neuropathy,
             Guillain-Barré or spinal cord injury;

          -  Have S. aureus pneumonia, empyema, meningitis, or endocarditis