Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being studied for the treatment of skin diseases and infectious conditions, specifically complicated skin and soft tissue infections (cSSTI) and bacterial skin diseases. It is being evaluated in adolescents aged 12 years and older.
Tedizolid Phosphate is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange. The company is conducting clinical research on this investigational drug for skin infections.
Tedizolid Phosphate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under clinical investigation for its proposed indications.
Tedizolid Phosphate has one completed Phase 3 clinical trial, identified as NCT02276482, titled "Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)". This trial enrolled 120 participants aged 12 years and older.
Tedizolid Phosphate is a small molecule antibiotic that works by inhibiting bacterial protein synthesis. It targets the bacterial ribosome, specifically the 50S subunit, to prevent the growth and spread of bacteria that cause skin and soft tissue infections.