A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate
(MK-1986) compared with comparator antibacterial agent in participants from birth to less
than 12 years of age with acute bacterial skin and skin structure infections.
Participants will be randomized (3:1) to receive tedizolid phosphate at a weight-based dose
200 mg/day, intravenous (IV) and/or oral suspension for 6 to 10 days, or comparator IV
and/or oral per local standard of care for 10 to 14 days. The switch from IV to oral
administration can be made at any time based on 1) no worsening of the primary skin lesion,
2) last temperature <37.7 C, and 3) primary acute bacterial skin and skin structure
infection (ABSSSI) site has not worsened and at least 1 site has improved from Baseline. The
potential 4-day treatment extension will be based on clinical need as judged by the
investigator, considering the following criteria: 1) 40% reduction in primary lesion size,
2) reduction in pain, and 3) no new signs and symptoms and no complications attributable to
ABSSSI compared with Baseline.
Acute Bacterial Skin and Skin Structure Infections
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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