NCT02276482

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

Phase 3 Study of IV to Oral 6-Day Tedizolid Phosphate Compared With 10-day Comparator in Subjects 12 to < 18 Years With cSSTI.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200 mg tedizolid phosphate with 10-day comparator in participants 12 to \<18 years with cSSTI.

Detailed description

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.

Conditions

• Skin Diseases, Infectious
• Skin Diseases, Bacterial

Interventions

Type	Name	Description
DRUG	Tedizolid Phophate	Tedizolid Phophate 200 mg, IV and/or oral for 6 days
DRUG	Antibiotic comparator	Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.
DRUG	Aztreonam	In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.
DRUG	Metronidazole	Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.

Timeline

• Start date: 2015-03-25
• Primary completion: 2018-09-17
• Completion: 2018-09-17
• First posted: 2014-10-28
• Last updated: 2019-08-07
• Results posted: 2019-08-07

Regulatory

• FDA-regulated drug study