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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01252719 | Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I) | PHASE3 | COMPLETED | 968 | — | — | Dec 1, 2010 | Nov 30, 2012 | Aug 1, 2022 | 1 | United States |
| NCT01252732 | Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection | PHASE3 | COMPLETED | 1,019 | — | — | Dec 1, 2010 | Jun 1, 2013 | May 5, 2021 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | EXPERIMENTAL | - |
| IV Vancomycin | ACTIVE_COMPARATOR | - |
| 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). |
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 ...