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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
Also known as TR701-122, MK-1986, SIVEXTRO®
Tedizolid Phophate · 1 trial · 2 indications
An adverse event (AE) refers to a treatment-emergent adverse event (TE-AE). A TE-AE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.
| Arm | Type | Description |
|---|---|---|
| Tedizolid Phosphate | EXPERIMENTAL | Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral). |
| Antibiotic comparator drug | ACTIVE_COMPARATOR | IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral). |
| Name | Type | Description |
|---|---|---|
| Tedizolid Phophate | DRUG | Tedizolid Phophate 200 mg, IV and/or oral for 6 days |
| Antibiotic comparator | DRUG | Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin. |
| Aztreonam | DRUG | In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens. |
| Metronidazole | DRUG | Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens. |
Inclusion Criteria: * Males or females 12 years to \<18 years * Adequate venous access for IV administration of study drug for at least 24 hours (for participants receiving IV medication) and collection of protocol-specified blood samples * Local symptoms must have started within 7 days before Stud...
Tedizolid Phosphate is being studied for the treatment of skin diseases and infectious skin conditions, specifically complicated skin and soft tissue infections. It is an investigational small molecule developed by Merck & Company, Inc. for use in dermatology and infectious disease settings.
Tedizolid Phosphate is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical development of the drug for infectious skin diseases.
Tedizolid Phosphate is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the studied indication. The Phase 3 trial has been completed.
Tedizolid Phosphate has been evaluated in one completed Phase 3 trial, NCT02276482, titled Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012). The trial enrolled 120 participants, was randomized, and used an active-controlled design.
Tedizolid Phosphate is a small molecule, but its specific molecular target is not provided in the available information. It is being developed for infectious skin diseases and complicated skin and soft tissue infections.