Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
Condition: Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Infectious; Skin Diseases
Intervention: Daptomycin; Standard of Care (SOC)
Intervention MeSH terms: Daptomycin; Cloxacillin; Oxacillin; Nafcillin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 396.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Complicated; Skin; Structure

Summary:

      This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
      the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to
      17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by
      Gram-positive pathogens.
    

Eligibility criteria:

        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