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

Phase 3 Completed 100 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

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

Timeline

Start: 2019-01-20
Primary completion: 2023-07-06
Completion: 2023-07-06

Publications

Results Mngqibisa R, Fofanov O, Grazioso CF, Melgar Toledo M, Boddicker M, Broyde N, Koseoglu S, Romero L, Stevens M, Sears P. A Phase 3 Study of the Safety and Efficacy of Tedizolid Phosphate in Patients <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections. Pediatr Infect Dis J. 2025 Jun 1;44(6):533-538. doi: 10.1097/INF.0000000000004807. Epub 2025 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	CEPHALEXIN ANHYDROUS	Small molecule	—	Oral
Comparator	Cefazolin	Small molecule	—	Intravenous
Comparator	Clindamycin	Unknown	—	Intravenous
Comparator	FLOXACILLIN	Small molecule	—	Intravenous
Comparator	Linezolid	Other / unclassified	—	Intravenous
Subject	Tedizolid Phosphate	Small molecule	2 mg/kg	Intravenous
Subject	Tedizolid Phosphate	Small molecule	2.5 mg/kg	Intravenous
Subject	Tedizolid Phosphate	Small molecule	200 mg	Intravenous
Comparator	Vancomycin	Other / unclassified	—	Intravenous

Indications

No indication recorded.