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TR-701 FA

DRUG7 trials

Sponsors

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Conditions

Bacterial InfectionHealthy SubjectsHepatic ImpairmentRenal ImpairmentSkin and Subcutaneous Tissue Bacterial Infections

Phase 1

Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
CompletedNCT01156077
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Bacterial Infection
Start: 2010-06-02End: 2011-09-24Updated: 2018-12-07
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg
CompletedNCT01271998
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Bacterial Infection
Start: 2010-12-08End: 2011-01-03Updated: 2019-11-15
A PK and Safety Study in Subjects With Hepatic Impairment
CompletedNCT01431833
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Hepatic Impairment
Start: 2011-08-31End: 2012-05-31Updated: 2016-05-20
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
CompletedNCT01452828
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Renal Impairment
Start: 2011-10-31End: 2012-03-31Updated: 2016-05-03
A Phase 1, Open-Label, 10 Day Safety Study
CompletedNCT01623401
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Healthy Subjects
Start: 2012-05-17End: 2012-08-24Updated: 2017-10-06

Phase 3

TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
CompletedNCT01170221
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Skin and Subcutaneous Tissue Bacterial Infections
Start: 2010-08-15End: 2011-09-30Updated: 2018-08-29
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
CompletedNCT01421511
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Skin and Subcutaneous Tissue Bacterial Infections
Start: 2011-09-15End: 2013-01-10Updated: 2018-08-29

Related Papers

Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy.
2019-07-0513 citations
Comparison of the microbiological efficacy of tedizolid and linezolid in acute bacterial skin and skin structure infections: pooled data from phase 3 clinical trials.
2019-01-305 citations
Efficacy and Safety of Tedizolid and Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Injection Drug Users: Analysis of Two Clinical Trials.
2018-09-2110 citations
Outpatient treatment of acute bacterial skin and skin structure infections (ABSSSI) with tedizolid phosphate and linezolid in patients in the United States: Subgroup analysis of 2 randomized phase 3 trials.
2017-12-015 citations
Clinical Response of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections by Severity Measure Using a Pooled Analysis from Two Phase 3 Double-Blind Trials
Antimicrobial Agents and Chemotherapy2017-03-0722 citations
Characterization of Neurologic and Ophthalmologic Safety of Oral Administration of Tedizolid for Up to 21 Days in Healthy Volunteers.
2017-03-0115 citations
Early Clinical Response as a Predictor of Late Treatment Success in Patients With Acute Bacterial Skin and Skin Structure Infections: Retrospective Analysis of 2 Randomized Controlled Trials
Clinical Infectious Diseases2016-12-0818 citations
Tedizolid and Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections of the Lower Extremity versus Non-Lower-Extremity Infections<sub>Pooled Analysis of Two Phase 3 Trials</sub>.
2016-08-176 citations
Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain.
2016-08-138 citations
Analysis of the Phase 3 ESTABLISH Trials of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections
Antimicrobial Agents and Chemotherapy2014-11-25140 citations
Platelet Profile in Patients with Acute Bacterial Skin and Skin Structure Infections Receiving Tedizolid or Linezolid: Findings from the Phase 3 ESTABLISH Clinical Trials
Antimicrobial Agents and Chemotherapy2014-09-2368 citations
Pharmacokinetics of Tedizolid in Subjects with Renal or Hepatic Impairment
Antimicrobial Agents and Chemotherapy2014-08-1960 citations
Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial.
2014-06-05228 citations
Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial.
2013-02-01263 citations