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Also known as Single-Dose IV Oritavancin Diphosphate
Single-Dose Oritavancin Diphosphate · 2 trials · 4 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.
| 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 ...
Single-Dose Oritavancin Diphosphate is an investigational small molecule antibiotic being developed by CorMedix Inc. (ticker CRMD) for the treatment of wound infection. It is administered as a single intravenous dose and is currently in Phase 3 clinical development. The drug has been studied in two completed Phase 3 trials with a total enrollment of 1,987 patients.
Single-Dose Oritavancin Diphosphate is being developed for the treatment of wound infection. Its clinical trials have also enrolled patients with abscess, systemic inflammation, and cellulitis. The program is in Phase 3 development, and the drug is not yet approved for any indication.
Single-Dose Oritavancin Diphosphate is being developed by CorMedix Inc., which trades under the ticker CRMD. CorMedix is the sponsor of the clinical development program for this investigational antibiotic.
Single-Dose Oritavancin Diphosphate is in Phase 3 clinical development. Both of its Phase 3 trials have been completed, and there are currently no active trials. The drug remains investigational and has not been approved by the FDA for any indication.
Single-Dose Oritavancin Diphosphate has been evaluated in two completed Phase 3 trials. NCT01252732 compared oritavancin with intravenous vancomycin in 1,019 patients with acute bacterial skin and skin structure infection. NCT01252719, known as SOLO I, compared oritavancin with intravenous vancomycin in 968 patients with the same condition. Both trials were conducted in the United States.
Yes, Single-Dose Oritavancin Diphosphate is also known as Single-Dose IV Oritavancin Diphosphate. The alternative name Single-Dose IV Oritavancin Diphosphate and Warfarin also refers to the same drug program. These names describe the same investigational antibiotic developed by CorMedix Inc. for wound infection.