Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)

A randomized, single-blind, multicenter, Phase 3 study of IV and/or oral tedizolid phosphate
200 mg once per day for 6 days compared with IV and/or oral Comparator for 10 days for the
treatment of cSSTI, also known as acute bacterial skin and skin structure infections, in
participants 12 to <18 years. cSSTI includes major cutaneous abscess, cellulitis/erysipelas,
and wound infection.

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