Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Summary

A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Timeline

Start

2007-07-18

Primary completion

2008-01-07

Completion

2008-01-07

Outcome

Mixed primary results

registry analysis (superiority test); Omadacycline vs Linezolid; Mean Difference (Final Values) 13.6 (95% CI 1.3 to 26.0) NCT03716024 ↗

registry analysis (superiority test); Omadacycline vs Linezolid; Mean Difference (Final Values) 4.8 (95% CI -1.7 to 11.4) NCT03716024 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Linezolid	Other / unclassified	600 mg	Intravenous
Subject	Omadacycline	Small molecule	100 mg	Intravenous

Indications