Study of Tedizolid Phosphate in Adolescents With cSSTI.

The purpose of the study is to comparator the safety of IV to oral 6-day 200 mg tedizolid phosphate with 10-day comparator in subjects 12 to <18 years with cSSTI.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of IV to Oral 6-Day Tedizolid Phosphate Compared With 10-day Comparator in Subjects 12 to < 18 Years With cSSTI.
Estimated Enrollment: 162
Study Start Date: December 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Tedizolid Phosphate IV to oral 200 mg once per day for 6 days
- Active Comparator: Antibiotic comparator drug IV to oral antibiotic comparator drug for 10 days