CLINICAL TRIALS PROFILE FOR TEDIZOLID PHOSPHATE
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All Clinical Trials for tedizolid phosphate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01170221 ↗ | TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. | Completed | Trius Therapeutics LLC | Phase 3 | 2010-08-15 | 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 |
| NCT01539473 ↗ | A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge | Completed | Trius Therapeutics LLC | Phase 1 | 2012-02-01 | Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine |
| NCT01577459 ↗ | A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response | Completed | Trius Therapeutics LLC | Phase 1 | 2012-04-23 | This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers. |
| NCT01623401 ↗ | A Phase 1, Open-Label, 10 Day Safety Study | Completed | Trius Therapeutics LLC | Phase 1 | 2012-05-17 | This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days and will include ophthalmologic and neurologic assessments. |
| NCT02019420 ↗ | Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002) | Completed | Cubist Pharmaceuticals LLC | Phase 3 | 2014-01-06 | 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 > -10). |
| NCT02066402 ↗ | Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2014-03-04 | This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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