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

Phase 3 Completed 120 enrolled Merck & Co., Inc.

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2015-03-25
Primary completion: 2018-09-17
Completion: 2018-09-17

Publications

Bradley JS, Antadze T, Ninov B, Tayob MS, Broyde N, Butterton JR, Chou MZ, De Anda CS, Kim JY, Sears PS. Safety and Efficacy of Oral and/or Intravenous Tedizolid Phosphate From a Randomized Phase 3 Trial in Adolescents With Acute Bacterial Skin and Skin Structure Infections. Pediatr Infect Dis J. 2021 Mar 1;40(3):238-244. doi: 10.1097/INF.0000000000003010.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	CEPHALEXIN ANHYDROUS	Small molecule	—	Intravenous
Comparator	Cefazolin	Small molecule	—	Intravenous
Comparator	Clindamycin	Unknown	—	Intravenous
Comparator	FLOXACILLIN	Small molecule	—	Intravenous
Comparator	Linezolid	Other / unclassified	—	Intravenous
Subject	Tedizolid	Small molecule	200 mg	Intravenous
Comparator	Vancomycin	Other / unclassified	—	Intravenous
Background	Aztreonam	Small molecule	—	Intravenous
Background	Metronidazole	Small molecule	—	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications