NCT02378480

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 655 (actual)
• Sponsor: Paratek Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.

Conditions

• Bacterial Infections
• Skin Structures and Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	Omadacycline	Injection for IV dosing; Tablets for oral dosing
DRUG	Linezolid	Infusion solution for IV dosing; Tablets for oral dosing

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2015-03-04
• Last updated: 2019-03-21
• Results posted: 2019-03-21

Locations

78 sites across 14 countries: United States, Bulgaria, Croatia, Greece, Hungary, Israel, Latvia, Peru, Poland, Romania, South Africa, Spain, Turkey (Türkiye), Ukraine