Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VIBATIV®, TD-6424, ASP9809
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 studied for gram-positive bacterial infections, including hospital-acquired bacterial pneumonia caused by methicillin-resistant Staphylococcus aureus and complicated skin and skin structure infections, also with a focus on MRSA. It has also been evaluated in patients with kidney diseases, including end stage renal disease.
Telavancin is being developed by Cumberland Pharmaceuticals Inc., which trades under the ticker CPIX. The company is the sponsor behind the clinical development program for this small molecule antibiotic in infectious disease indications.
Telavancin is in Phase 3 clinical development. Three completed Phase 3 trials have evaluated it in bacterial pneumonia and staphylococcal skin infection, and a Phase 1 study examined the effect of renal function on its biological activity. It is investigational and has not been established as approved.
Telavancin has been studied in completed trials including NCT00124020 and NCT00107952, both Phase 3 comparisons with vancomycin for hospital-acquired pneumonia due to methicillin-resistant Staphylococcus aureus, NCT00107978, a Phase 3 comparison with vancomycin in complicated skin and skin structure infections, and NCT01238796, a Phase 1 renal function study.
Across the four listed telavancin studies, total enrollment was 1,897 participants. The Phase 3 trials were randomized, double-blind, and active-controlled, comparing telavancin against vancomycin, while the Phase 1 renal function study enrolled 45 healthy volunteers.