Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

• Status: Completed
• Trial end date: 2016-01-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Cephalosporins; Clindamycin; Daptomycin; Penicillins; Vancomycin

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