Approval Probability
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Adjusted LOA
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Telavancin · 8 trials · 11 indications
Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection * Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. * Indeterminate: Inability to determine outcome
* Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit * Indeterminate: Inability to determine outcome.
Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.
| Arm | Type | Description |
|---|---|---|
| Telavancin | EXPERIMENTAL | - |
| Vancomycin | ACTIVE_COMPARATOR | - |
| Standard of care for cSSSI | ACTIVE_COMPARATOR | cSSSI - comlicated skin and skin structure infections |
| Vancomycin, nafcillin, oxacillin, or cloxacillin | ACTIVE_COMPARATOR | Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously |
| Normal renal function | EXPERIMENTAL | Subjects with normal renal function |
| Severe renal impairment | EXPERIMENTAL | Subjects with severe renal impairment |
| End stage renal disease | EXPERIMENTAL | Subjects with end stage renal disease |
| Name | Type | Description |
|---|---|---|
| Telavancin | DRUG | Telavancin 10 mg/kg/day IV for up to 21 days. |
| Vancomycin | DRUG | Vancomycin 1 Gm IV q 12 hrs for up to 21 days |
| vancomycin or antistaphylococcal penicillin | DRUG | Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days. |
| Vancomycin, nafcillin, oxacillin, or cloxacillin | DRUG | Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days. |
Inclusion Criteria: * Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration. Exclus...
Telavancin is an investigational small molecule antibiotic in Phase 3 development for complicated skin and skin structure infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. It is also being studied for use in kidney diseases and bacterial pneumonia. Telavancin is being developed by Cumberland Pharmaceuticals Inc. (CPIX).
Telavancin is a lipoglycopeptide antibiotic that targets Gram-positive bacteria by inhibiting cell wall synthesis and disrupting the bacterial cell membrane. It is being studied for its activity against methicillin-resistant Staphylococcus aureus and other Gram-positive pathogens. The drug is in Phase 3 clinical development for complicated skin infections.
Telavancin is being developed by Cumberland Pharmaceuticals Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol CPIX. The company is conducting clinical trials to evaluate the drug for the treatment of Gram-positive bacterial infections, including complicated skin and skin structure infections.
Telavancin is in Phase 3 clinical development for the treatment of complicated skin and skin structure infections. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed, including two Phase 3 studies comparing telavancin to vancomycin in patients with methicillin-resistant Staphylococcus aureus infections.
Telavancin has completed several clinical trials, including NCT00091819 and NCT00107978, both Phase 3 studies comparing telavancin to vancomycin for complicated skin and skin structure infections. A Phase 2 trial, NCT00062647, evaluated telavancin for uncomplicated Staphylococcus aureus bacteremia. A Phase 1 study, NCT01238796, assessed the effect of renal function on telavancin's biological activity.
Telavancin is the same drug as Vibativ, which is a brand name for telavancin. Vibativ is the marketed name for telavancin, and both names refer to the same antibiotic agent. Cumberland Pharmaceuticals Inc. is the developer of telavancin, and the drug is being studied for Gram-positive bacterial infections.