Trial reportAntimicrobial agents and chemotherapy2011
Phase 2, randomized, double-blind, dose-ranging study evaluating the safety, tolerability, population pharmacokinetics, and efficacy of oral torezolid phosphate in patients with complicated skin and skin structure infections.
Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Antibiotic therapy for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) in non surgical wounds.The Cochrane database of systematic reviews · 2013Pooled it
- 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 chemotherapy · 2014Trial
- Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment.Antimicrobial agents and chemotherapy · 2014Trial
- Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid.Pharmacotherapy · 2014Trial
- Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug.Pharmacotherapy · 2014Trial
- In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions.Antimicrobial agents and chemotherapy · 2013Trial
- In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections.Antimicrobial agents and chemotherapy · 2012Trial
- Phase 2, randomized, double-blind, dose-ranging study evaluating the safety, tolerability, population pharmacokinetics, and efficacy of oral torezolid phosphate in patients with complicated skin and skin structure infections.Antimicrobial agents and chemotherapy · 2011Trial
- Efficacy, safety, tolerability and population pharmacokinetics of tedizolid, a novel antibiotic, in Latino patients with acute bacterial skin and skin structure infections.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesTrial
- Advances in Therapeutic Drug Monitoring and Pharmacokinetic Researches of Oxazolidinone Antibacterial Agents in the Elderly Patients.Clinical interventions in aging · 2026Review
- Population pharmacokinetic rationale for intravenous contezolid acefosamil followed by oral contezolid dosage regimens.Antimicrobial agents and chemotherapy · 2024Article
- Insufficient Representation of Patients With Obesity in Randomized Controlled Trials Evaluating the Efficacy and Safety of Antimicrobials for Treatment of Skin and Skin Structure Infections: A Scoping Review.Open forum infectious diseases · 2023Article
- Pharmacokinetics and Pharmacodynamics of Tedizolid.Clinical pharmacokinetics · 2022Review
- Importance and Reality of TDM for Antibiotics Not Covered by Insurance in Japan.International journal of environmental research and public health · 2022Review
- Therapeutic Drug Monitoring in Non-Tuberculosis Mycobacteria Infections.Clinical pharmacokinetics · 2021Review
- Tedizolid vs Linezolid for the Treatment of Nontuberculous Mycobacteria Infections in Solid Organ Transplant Recipients.Open forum infectious diseases · 2021Article
- Tedizolid Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection: A Systematic Review and Meta-Analysis.Antibiotics (Basel, Switzerland) · 2019Article
- Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy.Core evidence · 2019Article
- Pharmacokinetics of Tedizolid in Plasma and Sputum of Adults with Cystic Fibrosis.Antimicrobial agents and chemotherapy · 2018Article
- Long-term Use of Tedizolid as Suppressive Therapy for Recurrent Methicillin-Resistant Staphylococcus aureus Graft Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Torezolid (TR-700) is the active moiety of the prodrug torezolid phosphate ([TP] TR-701), a second-generation oxazolidinone with 4- to 16-fold greater potency than linezolid against Gram-positive species including methicillin-resistant Staphylococcus aureus (MRSA). A double-blind phase 2 study evaluated three levels (200, 300, or 400 mg) of oral, once-daily TP over 5 to 7 days for complicated skin and skin structure infections (cSSSI). Patients 18 to 75 years old with cSSSI caused by suspected or confirmed Gram-positive pathogens were randomized 1:1:1. Of 188 treated patients, 76.6% had abscesses, 17.6% had extensive cellulitis, and 5.9% had wound infections. S. aureus, the most common pathogen, was isolated in 90.3% of patients (139/154) with a baseline pathogen; 80.6% were MRSA. Cure rates in clinically evaluable patients were 98.2% at 200 mg, 94.4% at 300 mg, and 94.4% at 400 mg. Cure rates were consistent across diagnoses, regardless of lesion size or the presence of systemic signs of infection. Clinical cure rates in patients with S. aureus isolated at baseline were 96.6% overall and 96.8% for MRSA. TP was safe and well tolerated at all dose levels. No patients discontinued treatment due to an adverse event. Three-stage hierarchical population pharmacokinetic modeling yielded a geometric mean clearance of 8.28 liters/h (between-patient variability, 32.3%), a volume of the central compartment of 71.4 liters (24.0%), and a volume of the peripheral compartment of 27.9 liters (35.7%). Results of this study show a high degree of efficacy at all three dose levels without significant differences in the safety profile and support the continued evaluation of TP for the treatment of cSSSI in phase 3 trials.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.