Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single-Dose Oritavancin Diphosphate · 4 trials · 5 indications
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication. A participant was classified as "success" if all of the following were met: cessation of spread or reduction of the lesion (defined as cessation of spread of the redness, edema, and/or induration or reduction in size \[length, width, and area\] of the redness, edema, and/or induration such that the size of the lesion was less than or equal to the size at baseline); resolution (absence) of fever (temperature \<37.7°Celsius at the last 3 consecutive recordings by the same route of administration taken 4 times per day, for example every 6 hours between 48 and 72 hours); no rescue antibiotic medication.
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on, cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication.
Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo.
| Arm | Type | Description |
|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | EXPERIMENTAL | - |
| IV Vancomycin | ACTIVE_COMPARATOR | - |
| Oritavancin | EXPERIMENTAL | Single-Dose IV Oritavancin Diphosphate |
| Placebo | PLACEBO_COMPARATOR | Single-dose IV placebo |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin tablet |
| Name | Type | Description |
|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | DRUG | Oritavancin was administered as a single IV dose. |
| IV Vancomycin | DRUG | Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days. |
| Placebo | DRUG | Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo). |
| Moxifloxacin | DRUG | Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion. |
Inclusion Criteria: Participants were included in the study if they met all of the following inclusion criteria: 1. Males or females ≥18 years old 2. Diagnosis of ABSSSI suspected or confirmed to be caused by a gram-positive pathogen requiring at least 7 days of IV therapy 3. An ABSSSI included 1 ...