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

This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years,
inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into
age groups and given age-dependent doses over a period of up to 14 days. Participants will be
stratified by age group to receive either daptomycin or SOC (recommended as vancomycin,
clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may
continue on oral therapy following completion of IV study drug administration and provided
that the participant meets all criteria for conversion to oral therapy, including clear
clinical improvement and availability of an oral agent to which the pathogen is susceptible.
The choice of oral therapy will be left to the discretion of the Investigator. February 11,
2015 released from post marketing requirement to include subjects aged 3 months - < 1 year.
Ref ID: 3701325

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

Exclusion Criteria:

- Investigational drug use (including daptomycin) or participation in any experimental
procedure in the 30 days preceding study entry

- Known allergy/hypersensitivity to daptomycin

- Known infection caused solely by Gram-negative pathogen(s), fungus(i), or virus(es)

- Previous systemic antimicrobial therapy exceeding 24 hours in duration administered
anytime during the 48 hours prior to the first dose of study drug (exception: a
participant is eligible if on previous antibiotics without any clinical improvement
and/or a wound culture is available and the pathogen is not sensitive to prior
therapy)

- 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