Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02276482 | Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) | PHASE3 | COMPLETED | 120 | — | — | Mar 25, 2015 | Sep 17, 2018 | Aug 7, 2019 | - | — |
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...