MedPath

Tedizolid

Generic Name
Tedizolid
Brand Names
Sivextro
Drug Type
Small Molecule
Chemical Formula
C17H15FN6O3
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)

A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)

First Posted Date
2024-12-13
Last Posted Date
2024-12-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
36
Registration Number
NCT06733688
Locations
🇺🇸

Celerion (Site 0001), Lincoln, Nebraska, United States

A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)

First Posted Date
2024-09-24
Last Posted Date
2024-09-24
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
18
Registration Number
NCT06609161
Locations
🇺🇸

Celerion (Site 0001), Lincoln, Nebraska, United States

Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)

Phase 2
Recruiting
Conditions
Tuberculosis
Multidrug Resistant Tuberculosis
Interventions
First Posted Date
2022-09-09
Last Posted Date
2025-02-03
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
60
Registration Number
NCT05534750
Locations
🇫🇷

Bacteriology department- Hôpital Saint-Antoine, Paris, France

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

First Posted Date
2022-06-01
Last Posted Date
2025-03-11
Lead Sponsor
Fundacion Clinic per a la Recerca Biomédica
Target Recruit Count
360
Registration Number
NCT05398679
Locations
🇪🇸

Hospital Virgen de la Macarena, Sevilla, Andalucía, Spain

🇪🇸

Hospital Virgen del Rocío, Sevilla, Andalucía, Spain

🇪🇸

Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain

and more 17 locations

Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal

Phase 4
Completed
Conditions
Prostheses Infection
Interventions
First Posted Date
2018-11-19
Last Posted Date
2025-03-12
Lead Sponsor
Fundacion Clinic per a la Recerca Biomédica
Target Recruit Count
30
Registration Number
NCT03746327
Locations
🇪🇸

Laura Morata, Barcelona, Spain

Tedizolid Prolonged Treatment for Prosthetic Joint Infections

Not Applicable
Completed
Conditions
Prosthetic Joint Infection
Interventions
First Posted Date
2017-12-19
Last Posted Date
2021-09-08
Lead Sponsor
Tourcoing Hospital
Target Recruit Count
35
Registration Number
NCT03378427
Locations
🇫🇷

Hôpital Ambroise Paré, Boulogne-Billancourt, France

🇫🇷

Hôpital de la Croix Rousse, Lyon, France

A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

Phase 1
Completed
Conditions
Gram-Positive Infections
Interventions
First Posted Date
2017-07-14
Last Posted Date
2025-02-11
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
47
Registration Number
NCT03217565
Locations
🇧🇬

MHAT Rousse-Neonatology ( Site 2213), Ruse, Bulgaria

🇧🇬

Multiprofile Hospital for Active Treatment - Ruse ( Site 2204), Ruse, Bulgaria

🇺🇸

Arkansas Children's Hospital ( Site 1012), Little Rock, Arkansas, United States

and more 27 locations

A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

Phase 3
Completed
Conditions
Acute Bacterial Skin and Skin Structure Infections
Interventions
First Posted Date
2017-06-05
Last Posted Date
2024-07-03
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
100
Registration Number
NCT03176134
Locations
🇺🇸

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129), Chicago, Illinois, United States

🇧🇷

Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277), Recife, Pernambuco, Brazil

🇧🇬

UMHAT Deva Maria ( Site 0333), Burgas, Bulgaria

and more 55 locations

Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER)

Phase 2
Completed
Conditions
Bone and Joint Infection
Interventions
First Posted Date
2017-01-04
Last Posted Date
2023-12-13
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Target Recruit Count
44
Registration Number
NCT03009045
Locations
🇺🇸

Harbor-UCLA Medical Center, Torrance, California, United States

🇺🇸

Los Angeles BioMedical Research Institute (LA BioMed), Torrance, California, United States

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

Terminated
Conditions
Skin Disease, Infectious
Interventions
First Posted Date
2016-12-13
Last Posted Date
2019-10-02
Lead Sponsor
Bayer
Target Recruit Count
108
Registration Number
NCT02991131
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