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 ...
Single-Dose Oritavancin Diphosphate is an investigational small molecule being studied for the treatment of wound infections, including acute bacterial skin and skin structure infections such as abscess, systemic inflammation, and cellulitis. It is also being evaluated in healthy volunteers for safety and drug interaction studies.
Single-Dose Oritavancin Diphosphate is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Single-Dose Oritavancin Diphosphate is in Phase 1 clinical development. It has completed two Phase 1 trials in healthy volunteers, and it has also completed two Phase 3 trials for wound infections, although the overall development program is currently listed as Phase 1.
Single-Dose Oritavancin Diphosphate has completed four clinical trials. NCT01252719 and NCT01252732 were Phase 3 studies comparing oritavancin to IV vancomycin in patients with acute bacterial skin and skin structure infections. NCT01762839 assessed cardiac safety in healthy participants, and NCT01784536 evaluated effects on cytochrome P450 in healthy volunteers.
Single-Dose Oritavancin Diphosphate is a formulation of oritavancin, a lipoglycopeptide antibiotic. The clinical trials listed under this drug name evaluate oritavancin as a single-dose regimen for skin infections. It is not a different drug but a specific dosing and formulation approach.
Single-Dose Oritavancin Diphosphate is a small molecule antibiotic that targets bacterial cell wall synthesis. It is being studied for its ability to treat wound infections caused by susceptible bacteria, including those involving abscess and cellulitis, by inhibiting bacterial growth and promoting clearance of the infection.