Last updated on August 2019

A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

Brief description of study

This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to <12 years of age with acute bacterial skin and skin structure infections.

Detailed Study Description

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.

Clinical Study Identifier: NCT03176134

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Setshaba Research Centre ( Site 0378)

Pretoria, South Africa
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