Linezolid

Generic Name: Linezolid

Brand Names: Zyvox, Zyvoxam

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₂₀FN_₃O_₄

CAS Number: 165800-03-3

Unique Ingredient Identifier: ISQ9I6J12J

Background: Linezolid is a synthetic antibiotic which is used for the treatment of infections caused by aerobic Gram-positive bacteria. Its effects are bacteriostatic against both enterococci and staphylococci and bactericidal against most isolates of streptococci. Linezolid exerts its antibacterial activity by inhibiting the initiation of bacterial protein synthesis - more specifically, it binds to the 23S ribosomal RNA of the 50S subunit and, in doing so, prevents the formation of the 70S initiation complex which is essential for bacterial reproduction.

Linezolid was initially approved in 2000 and was the first member of the oxazolidinone antibiotic class. A second member of this class, tedizolid, was approved by the FDA in 2014 and is considered generally more effective and tolerable than its predecessor.

Indication: Linezolid is indicated in adults and children for the treatment of infections caused by susceptible Gram-positive bacteria, including nosocomial pneumonia, community-acquired pneumonia, skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections. Examples of susceptible bacteria include Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Streptococcus agalactiae.

Linezolid is not indicated for the treatment of Gram-negative infections, nor has it been evaluated for use longer than 28 days.

Associated Conditions: Community Acquired Pneumonia (CAP) caused by Staphylococcus Aureus Infections, Community acquired pneumonia caused by Susceptible strains of Streptococcus pneumoniae, Complicated Skin and Skin Structure Infection caused by Staphylococcus Aureus Infections, Complicated Skin and Skin Structure Infection caused by Streptococcus Agalactiae Infection, Complicated Skin and Skin Structure Infection caused by Streptococcus Pyogenes Infection, Nosocomial Pneumonia caused by Staphylococcus Aureus Infections, Nosocomial Pneumonia caused by Streptococcus Pneumoniae Infections, Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus Aureus Infections, Uncomplicated Skin and Skin Structure Infections caused by Streptococcus Pyogenes Infection, Vancomycin-resistant Enterococcus faecium infection

Clinical Trials

Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

Phase 4

Conditions: Critical Illness
Mechanical Ventilation Complication

Interventions: Drug: placebo
Drug: ceftriaxone
Drug: ciprofloxacin
Drug: imipenem
Drug: linezolid

First Posted Date: 2017-01-06

Last Posted Date: 2022-08-17

Lead Sponsor: University Hospital, Lille

Target Recruit Count: 154

Registration Number: NCT03012360

Locations: 🇫🇷
Hôpital Roger Salengro, CHRU, Lille, France

Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

Terminated

Conditions: Skin Disease, Infectious

Interventions: Drug: Tedizolid (Sivextro, BAY1192631)
Drug: Linezolid

First Posted Date: 2016-12-13

Last Posted Date: 2019-10-02

Lead Sponsor: Bayer

Target Recruit Count: 108

Registration Number: NCT02991131

Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin

Phase 3

Withdrawn

Conditions: Tuberculosis Multi Drug Resistant Active

Interventions: Drug: WHO MDR-TB regimen
Drug: Delamanid
Drug: Linezolid
Drug: Levofloxacin
Drug: Pyrazinamide

First Posted Date: 2016-11-29

Last Posted Date: 2017-09-11

Lead Sponsor: Boston University

Registration Number: NCT02975570

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Phase 3

Completed

Conditions: Bacterial Infections
Skin Structures and Soft Tissue Infections

Interventions: Drug: Omadacycline
Drug: Linezolid

First Posted Date: 2016-08-24

Last Posted Date: 2018-11-30

Lead Sponsor: Paratek Pharmaceuticals Inc

Target Recruit Count: 735

Registration Number: NCT02877927

Locations: 🇺🇸
Site 620, Birmingham, Alabama, United States
🇺🇸
Site 606, Buena Park, California, United States
🇺🇸
Site 604, Chula Vista, California, United States

and more 47 locations

A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

Phase 2

Completed

Conditions: Pulmonary Tuberculosis

Interventions: Drug: LCB01-0371 800mg, QD
Drug: LCB01-0371 1200mg, QD
Drug: Zyvox 600mg, BID
Drug: LCB01-0371 400mg, BID
Drug: LCB01-0371 800mg, BID
Drug: Tubes 3~5Tablet, QD

First Posted Date: 2016-07-19

Last Posted Date: 2020-02-06

Lead Sponsor: LigaChem Biosciences, Inc.

Target Recruit Count: 79

Registration Number: NCT02836483

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis

Not Applicable

Completed

Conditions: Tuberculosis

Interventions: Drug: Linezolid

First Posted Date: 2016-05-20

Last Posted Date: 2019-02-04

Lead Sponsor: Fondation Hôpital Saint-Joseph

Target Recruit Count: 31

Registration Number: NCT02778828

Locations: 🇫🇷
Sanatorium du Petit Fontainebleau Centre Médical de Bligny, Briis-sous-Forges, Essonne, France

Evaluating Newly Approved Drugs for Multidrug-resistant TB

Phase 3

Completed

Conditions: Tuberculosis, Multidrug-Resistant
Infection, Bacterial
Pulmonary Tuberculoses

Interventions: Drug: Control arm MDR-TB regimen, consistent with WHO guidelines
Drug: Bedaquiline
Drug: Clofazimine
Drug: Delamanid
Drug: Moxifloxacin
Drug: Linezolid
Drug: Levofloxacin
Drug: Pyrazinamide

First Posted Date: 2016-04-28

Last Posted Date: 2025-02-10

Lead Sponsor: Médecins Sans Frontières, France

Target Recruit Count: 754

Registration Number: NCT02754765

Locations: 🇰🇿
City Centre of Phthisiopulmonology, Almaty, Kazakhstan
🇵🇰
The Indus Hospital, Karachi, Pakistan
🇰🇿
Center of Phthisiopulmonology of Almaty Health Department, Almaty, Kazakhstan

and more 9 locations

Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer

Phase 2

Terminated

Conditions: Neoplasms
Febrile Neutropenia

Interventions: Drug: CAZ-AVI
Drug: Vancomycin
Drug: Linezolid
Drug: Cefepime
Drug: Meropenem
Drug: Piperacillin/tazobactam

First Posted Date: 2016-04-08

Last Posted Date: 2017-07-21

Lead Sponsor: Forest Laboratories

Target Recruit Count: 2

Registration Number: NCT02732327

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

Phase 3

Completed

Conditions: Community Acquired Bacterial Pneumonia

Interventions: Drug: Moxifloxacin
Drug: Delafloxacin
Drug: Linezolid

First Posted Date: 2016-02-10

Last Posted Date: 2020-02-27

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 860

Registration Number: NCT02679573

Locations: 🇺🇦
Melinta 306 Study Site, Zhytomyr, Ukraine

Treatment Shortening of MDR-TB Using Existing and New Drugs

Phase 2

Completed

Conditions: Tuberculosis, Multidrug-Resistant

Interventions: Drug: Locally-used WHO-approved MDR-TB regimen in Korea
Drug: Linezolid
Drug: Delamanid
Drug: Levofloxacin
Drug: Pyrazinamide

First Posted Date: 2015-12-02

Last Posted Date: 2025-01-03

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 214

Registration Number: NCT02619994

Locations: 🇰🇷
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine, Seoul, Korea, Republic of

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