Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daptomycin · 1 trial · 1 indication
Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.
| Arm | Type | Description |
|---|---|---|
| Daptomycin | EXPERIMENTAL | Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. |
| Vancomycin or Semi-Synthetic Penicillins (SSPs) | ACTIVE_COMPARATOR | Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days. |
| Name | Type | Description |
|---|---|---|
| Daptomycin | DRUG | Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. |
| Vancomycin or Semi-Synthetic Penicillins (SSPs) | DRUG | Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days. |
Inclusion criteria: Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours. Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or witho...
Top 20 of 28 competitors
Daptomycin is an investigational small molecule being developed for the treatment of infections. It is currently being studied in elderly patients with complicated skin and soft tissue infections. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.
Daptomycin is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with infections.
Daptomycin is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The most recent trial for Daptomycin has been completed.
Daptomycin has one completed Phase 3 clinical trial registered as NCT01184872. This study compared the efficacy and safety of Daptomycin in elderly patients with complicated skin and soft tissue infections. The trial enrolled 120 participants across Austria, Germany, Italy, Russia, and Spain.
Daptomycin is the generic name of the drug, while Cubicin is a brand name. The clinical trial data provided refers to the drug as Daptomycin, and no alternative brand names are mentioned in the available information.