Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
Condition: Bacteremia; Soft Tissue Infections; Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Bacteremia; Soft Tissue Infections; Skin Diseases, Infectious; Skin Diseases
Intervention: Daptomycin for Injection
Intervention description: Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.
Intervention MeSH terms: Daptomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: methicillin-resistant S. aureus (MRSA) infections; complicated skin and soft tissue infections (cSSTI)

Summary:

      The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK)
      parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years
      with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive
      cocci.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requires treatment for cSSTI or bacteremia.

          -  Is male or female Japanese aged ≥ 1 to ≤ 17 years on the day of signing informed
             consent.

          -  As a male participant, has agreed to use contraception during the treatment period and
             for at least 14 days after the last dose of study treatment and refrain from donating
             sperm during this period.

          -  As a female participant, has agreed to participate if she is not pregnant, not
             breastfeeding, and at least one of the following conditions applies: not a woman of
             childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive
             guidance during the treatment period and for at least 14 days after the last dose of
             study treatment.

          -  Has agreed to allow any bacterial isolates obtained from protocol-required specimens
             related to the current infection to be provided the Central Microbiology Reference
             Laboratory for study-related microbiological testing, long-term storage, and other
             future testing.

        cSSTI Participants

          -  Has cSSTI known or suspected to be caused by gram-positive cocci that requires
             intravenous antibiotic treatment and diagnosed with either Gram stain or culture.

          -  Has at least 3 of the following clinical signs and symptoms associated with the cSSTI:
             pain, tenderness to palpation, temperature >37.0°C axillary or >37.5°C oral or >38.0°
             C rectal, forehead, or aural, white blood count (WBC) >12,000/mm^3 or ≥10% bands,
             swelling and/or induration, erythema (>1 cm beyond edge of wound or abscess), pus
             formation, CRP > upper limited of normal.

        Bacteremia Participants

          -  Have proven bacteremia with pathogen identification of gram-positive cocci at least
             one blood culture bottle by conventional culture methods or by a rapid diagnostic test
             in screening period.

          -  Have probable bacteremia with a blood culture result demonstrating gram-positive cocci
             by Gram stain in screening period.

        Exclusion Criteria:

          -  Has received previous systemic antimicrobial therapy that is effective against
             gram-positive cocci and exceeding 72 hours duration administered at any time during
             the 96 hours prior to the first dose of study drug.

          -  Has a known infection caused solely by gram-negative pathogen(s), fungus(i) or
             virus(es).

          -  Has pneumonia (septic emboli in the lung is not an exclusion if clear evidence of
             source of infection is other than lungs), empyema, meningitis, endocarditis, or
             osteoarticular infection.

          -  Has a history of or current rhabdomyolysis.

          -  Is anticipated to require non-study systemic antibiotics that may be potentially
             effective against gram-positive pathogen(s).

          -  Has shock or hypotension unresponsive to fluids or vasopressors for ≥ 4 hours.

          -  Has significant allergy/hypersensitivity or intolerance to daptomycin.

          -  Has renal insufficiency.

          -  Has a history of clinically significant (as assessed by the Investigator) muscular
             disease, nervous system or seizure disorder, including unexplained muscular weakness,
             history of peripheral neuropathy, Guillain-Barre or spinal cord injury; previous
             uncomplicated febrile seizure allowed.

          -  Has a history or current evidence of any condition, therapy, lab abnormality or other
             circumstance that might expose the participant to risk by participating in the trial,
             confound the results of the trial, or interfere with the participant's participation
             for the full duration of the trial.

          -  Is a female who is pregnant or is expecting to conceive (or is a male partner of a
             female who is expecting to conceive), is breastfeeding, or plans to breastfeed prior
             to completion of the study.

          -  Is currently participating in, or has participated in, any other clinical study
             involving the administration of investigational or experimental medication (not
             licensed by regulatory agencies) at the time of the presentation or during the
             previous 30 days prior to screening or is anticipated to participate in such a
             clinical study during the course of this trial.

          -  Has previously participated in this study at any time.

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or
             child) who is investigational site or sponsor staff directly involved with this study.