Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
linezolid · 7 trials · 8 indications
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia's formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.
| Arm | Type | Description |
|---|---|---|
| A. | EXPERIMENTAL | Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days. |
| B. | EXPERIMENTAL | - |
| Arm A | ACTIVE_COMPARATOR | - |
| Arm B | PLACEBO_COMPARATOR | - |
| Group 1 | OTHER | Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG. |
| Group 2 | OTHER | Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1: 900 mg linezolid | EXPERIMENTAL | - |
| Cohort 1: 1200 mg linezolid | EXPERIMENTAL | - |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 2: 600 mg linezolid | EXPERIMENTAL | - |
| Cohort 2: 1200 mg linezolid | EXPERIMENTAL | - |
| Cohort 2: 400 mg Moxifloxacin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| linezolid | DRUG | - |
| Vancomycin | DRUG | - |
| Oxacillin | DRUG | - |
| Dicloxacillin | DRUG | - |
| Placebo | DRUG | 500 mg oral placebo twice daily for 4.5 days |
| Linezolid 900 mg | DRUG | Intravenous, 900 mg linezolid, single dose |
| Linezolid 1200 mg | DRUG | Intravenous, 1200 mg linezolid, single dose |
| Linezolid 600 mg | DRUG | Intravenous, 600 mg linezolid, single dose |
| Moxifloxacin 400 mg | DRUG | Oral, 400 mg moxifloxacin, single dose |
Inclusion Criteria: * infection due to methicillin-resistant Staphylococcus aureus Exclusion Criteria: * hypersensitivity to linezolid
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