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Label indication SIVEXTRO is an oxazolidinone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible microorganisms in adult and pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg) ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the… FDA label
Tedizolid · 1 trial · 1 indication
Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
| Arm | Type | Description |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY1192631) | EXPERIMENTAL | Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO)) |
| Linezolid | ACTIVE_COMPARATOR | Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO)) |
| Name | Type | Description |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY1192631) | DRUG | BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia. |
| Linezolid | DRUG | Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia. |
Inclusion Criteria * Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection * Japanese Male and female patients aged 18 years or above * Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as the major cause of infection, with/without SST...
Tedizolid is used to treat infectious skin diseases, including skin infections caused by methicillin-resistant Staphylococcus aureus (MRSA). It is a small molecule antibacterial developed for dermatology indications. Clinical study NCT01967225 evaluated its safety and efficacy in Japanese patients with MRSA infections.
Tedizolid is developed by Bayer AG, which trades under the ticker BAYRY. The drug is also known as tedizolid phosphate and has been studied under the code BAY1192631.
Tedizolid has been studied in Phase 3 clinical development. One Phase 3 trial, NCT01967225, has been completed, and no trials are currently active. The completed study was randomized and active-controlled, enrolling 125 patients in Japan.
Tedizolid has been evaluated in the Phase 3 trial NCT01967225, titled "Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections." The trial enrolled 125 patients aged 18 years and older in Japan and is completed.
Yes. Tedizolid phosphate is an alternative name for tedizolid, and the compound has also been identified by the code BAY1192631 and the brand name Sivextro. All of these names refer to the same small molecule antibacterial agent.