TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
Trius Therapeutics LLC
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA
200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days
for the treatment of ABSSSI in adults.
Approximately 75 to 100 sites globally will participate in this study. Patients with an
ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be
randomized 1:1 to study treatment
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Cubist Pharmaceuticals LLC
This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3
study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus
linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of
ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia
(HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as
ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia
are to receive 14 days of active therapy in either treatment arm.
The primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM)
within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in
the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI >
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.