DeepMed Research

Tedizolid

Generic Name: Tedizolid

Brand Names: Sivextro

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₅FN_₆O_₃

CAS Number: 856866-72-3

Unique Ingredient Identifier: 97HLQ82NGL

Background: Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid.

Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO®). This product is currently available as both an oral tablet and as a powder for intravenous injection.

Indication: 用于特定的敏感细菌引起的成人急性细菌性皮肤和皮肤结构感染（ABSSSI）。抗菌谱为金黄色葡萄球菌(包括耐甲氧西林和甲氧西林敏感菌株)，化脓性链球菌，无乳链球菌，咽峡炎链球菌群(包括咽峡炎链球菌、中间型链球菌、星群链球菌)，粪肠球菌。

Associated Conditions: Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Clinical Trials

A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)

Phase 1

Completed

Conditions: Gram-Positive Bacterial Infections

Interventions: Drug: Tedizolid Phosphate (oral suspension)
Drug: Tedizolid Phosphate (IV)

First Posted Date: 2016-04-25

Last Posted Date: 2019-12-20

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 32

Registration Number: NCT02750761

Tedizolid Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Phase 1

Completed

Conditions: Diabetes
Wound Infection
Healthy Volunteers

Interventions: Drug: Tedizolid
Procedure: Microdialysis Catheter Insertion

First Posted Date: 2015-12-03

Last Posted Date: 2019-01-15

Lead Sponsor: Hartford Hospital

Target Recruit Count: 18

Registration Number: NCT02620787

Locations: 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States

A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)

Phase 1

Completed

Conditions: Skin Diseases, Bacterial

Interventions: Drug: midazolam
Drug: rosuvastatin
Drug: tedizolid phosphate

First Posted Date: 2015-06-22

Last Posted Date: 2015-08-24

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 18

Registration Number: NCT02477514

Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

Phase 4

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Tedizolid PO
Drug: Tedizolid IV

First Posted Date: 2015-05-14

Last Posted Date: 2020-06-02

Lead Sponsor: University of Southern California

Target Recruit Count: 11

Registration Number: NCT02444234

Locations: 🇺🇸
University of Southern California, Los Angeles, California, United States

Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults

Phase 4

Completed

Conditions: Obesity

Interventions: Drug: Tedizolid phosphate

First Posted Date: 2015-01-21

Last Posted Date: 2017-03-15

Lead Sponsor: Amit.Pai

Target Recruit Count: 19

Registration Number: NCT02342418

Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)

Phase 3

Completed

Conditions: Skin Diseases, Infectious
Skin Diseases, Bacterial

Interventions: Drug: Tedizolid Phophate
Drug: Antibiotic comparator
Drug: Aztreonam
Drug: Metronidazole

First Posted Date: 2014-10-28

Last Posted Date: 2019-08-07

Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 120

Registration Number: NCT02276482

Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: DA-7218
Drug: Placebo

First Posted Date: 2014-03-26

Last Posted Date: 2019-12-26

Lead Sponsor: Dong-A ST Co., Ltd.

Target Recruit Count: 31

Registration Number: NCT02097043

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

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)

Phase 3

Completed

Conditions: Bacterial Infections

Interventions: Drug: Placebo Tedizolid (BAY119-2631)
Drug: Tedizolid (BAY119-2631)
Drug: Linezolid
Drug: Placebo Linezolid

First Posted Date: 2014-02-19

Last Posted Date: 2017-06-07

Lead Sponsor: Bayer

Target Recruit Count: 598

Registration Number: NCT02066402

Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)

Phase 3

Completed

Conditions: Pneumonia

Interventions: Drug: Linezolid
Drug: Tedizolid phosphate

First Posted Date: 2013-12-24

Last Posted Date: 2019-06-27

Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 726

Registration Number: NCT02019420

Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections

Phase 3

Completed

Conditions: Skin Diseases, Infectious

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

First Posted Date: 2013-10-22

Last Posted Date: 2018-10-04

Lead Sponsor: Bayer

Target Recruit Count: 125

Registration Number: NCT01967225

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