Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
Condition: Skin Diseases, Infectious; Skin Diseases, Bacterial
MeSH terms: Communicable Diseases; Infections; Skin Diseases, Infectious; Skin Diseases, Bacterial; Skin Diseases
Intervention: Tedizolid Phophate; Antibiotic comparator; Aztreonam; Metronidazole
Intervention description: Tedizolid Phophate 200 mg, IV and/or oral for 6 days; Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.; In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.; Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Vancomycin; Clindamycin; Cefazolin; Linezolid; Cephalexin; Aztreonam; Tedizolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200
      mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 12 years to <18 years

          -  Adequate venous access for IV administration of study drug for at least 24 hours (for
             participants receiving IV medication) and collection of protocol-specified blood
             samples

          -  Local symptoms must have started within 7 days before Study Day -1

          -  cSSTI meeting at least 1 of the clinical syndrome definitions.

          -  Suspected or documented Gram-positive infection from baseline Gram stain or culture.

          -  Parent/legally authorized representative (LAR) able to give informed consent and
             willing and able to comply with all required study procedures. Assent is also required
             of children who in the Investigator's judgment are capable of understanding the nature
             of the study

        Exclusion Criteria:

          -  Uncomplicated minor skin and skin structure infections such as pustules, folliculitis,
             furuncles, minor abscesses (small volume of suppuration not surrounded by
             cellulitis/erysipelas), impetiginous lesions, superficial or limited
             cellulitis/erysipelas, and minor wound associated foreign body reactions (eg, stitch
             abscesses)

          -  Known bacteremia, severe sepsis or septic shock

          -  Recent history of opportunistic infections where the underlying cause of these
             infections is still active (eg, leukemia, transplant, acquired immunodeficiency
             syndrome)

          -  Hypersensitivity to tedizolid phosphate or any component in the formulation

          -  Hypersensitivity to all of the comparator drugs; hypersensitivity to a comparator drug
             does not preclude participation if an alternative comparator can be used

          -  For participants with wound infections: history of hypersensitivity to ceftazidime,
             aztreonam, or any component of the aztreonam formulation, if aztreonam adjunctive
             therapy is required; history of hypersensitivity to metronidazole or any component of
             the formulation, if metronidazole adjunctive therapy is required

          -  Needs oral administration of methotrexate, topotecan, irinotecan or rosuvastatin,
             during administration of oral study drug.

          -  Uses monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective
             serotonin reuptake inhibitors and serotonin 5 hydroxytryptamine receptor agonists
             (triptans) within 14 days prior to study drug administration