Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections

Inclusion Criteria

• •Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care
• •Written participant assent (as appropriate)
• •Male or female between the ages of 1 and 17 years old, inclusive
• •If female of childbearing potential (defined as post-menarche), not lactating or pregnant, documented negative pregnancy test result within 48 hours prior to study medication administration and willing to practice reliable birth control measures (at the discretion of the Principal Investigator) during study treatment and for at least 28 days after study completion
• •Able to comply with the protocol for the duration of the study
• •Skin and skin structure infections of a complicated nature known or suspected to be caused by Gram-positive pathogen(s) that require IV antibiotic treatment. Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (such as, infected ulcers, burns, and major abscesses) or infections in which the participant has a significant underlying disease state that complicates the response to treatment. The Investigator may contact the Medical Monitor to discuss infections not meeting this definition but which otherwise appear appropriate for inclusion
• •At least three of the following clinical signs and symptoms associated with the cSSSI: pain; tenderness to palpation; temperature \>37.5 degrees Celsius (C) (99.5 degrees Fahrenheit \[F\]) oral or \>38 degrees C (100.4 degrees F) rectal; white blood count (WBC) \>12,000/cubic millimeter (mm\^3) or ≥10% bands; swelling and/or induration; erythema (\>1 centimeter \[cm\] beyond edge of wound or abscess); or pus formation
• •Known or suspected pneumonia, osteomyelitis, meningitis, or endocarditis
• •Known bacteremia (exception: any participant enrolled in the study that is subsequently found to have a blood culture positive for bacteremia may be continued)
• •Participant with current or known clinically significant abnormal laboratory test results (including electrocardiograms \[ECGs\]) that would expose the participant to unacceptable risk as determined by Investigator
• •History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological, autoimmune disease, or primary immune deficiency (unless the Investigator considers that the subject would not be at risk by participating in the study \[Note: human immunodeficiency virus-infected participants must not be enrolled\])
• •History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system, or seizure disorder
• •Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre syndrome or spinal cord injury
• •Known or suspected renal insufficiency (that is, estimated creatinine clearance rate \[CLcr\]\<80 mL/min/1.73 squared meter \[m\^2\]
• •History of or current rhabdomyolysis
• •History of (within 1 year prior to first dose of study drug) or current myositis
• •Current septic shock
• •Known or suspected creatine phosphokinase (CPK) elevation