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A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Official Title: A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Participants will be randomized (3:1) to receive MK-1986 at a weight-based dose ≤200 mg/day, intravenous (IV) and/or oral suspension for 6 or 10 days, or comparator IV and/or oral per local standard of care for 10 or 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 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.

NCT03176134
Muller, William J., MD, PhD
Interventional
Yes

Contact Information:

Laura Fearn

Research Nurse

312.227.6285