Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daptomycin/kg · 1 trial · 1 indication
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT). MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline.
Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen.
| Arm | Type | Description |
|---|---|---|
| MK-3009 (daptomycin) 4 mg/kg | EXPERIMENTAL | - |
| Vancomycin | ACTIVE_COMPARATOR | - |
| MK-3009 (daptomycin) 6 mg/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Daptomycin 4 mg/kg | DRUG | MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI) |
| Comparator: vancomycin | DRUG | vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days |
| Daptomycin 6 mg/kg | DRUG | MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis |
Inclusion Criteria: * Both Sexes, Aged 20 Years Or Older * Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known Or Suspected To Be Caused By MRSA * Written Informed Consent Exclusion Criteria: * Participants With Skin and Soft Tissue infections That Can Be Treated ...
Daptomycin is a small molecule antibiotic studied for Gram-positive bacterial infections, including acute hematogenous osteomyelitis, bacterial endocarditis, bacterial pneumonia, and osteomyelitis. It is also being evaluated in pediatric patients with complicated skin and soft tissue infections and bacteremia. The drug is developed by Merck & Company, Inc. (MRK).
Daptomycin is a lipopeptide antibiotic that targets Gram-positive bacteria. It works by binding to the bacterial cell membrane and causing rapid depolarization, leading to disruption of membrane function and cell death. This mechanism makes it effective against a range of Gram-positive pathogens, including those resistant to other antibiotic classes.
Daptomycin is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various Gram-positive infections, including pneumonia and skin infections.
Daptomycin is in Phase 3 clinical development for bacterial pneumonia, as evidenced by a completed Phase 3 trial (NCT00540072). It has also completed Phase 1 and Phase 2 trials in pediatric populations. Daptomycin is investigational and not yet approved for these indications.
Daptomycin has been studied in several completed trials, including NCT00540072 (Phase 3 for bacterial pneumonia), NCT00679835 (Phase 1 in children with Gram-positive infections), NCT01019395 (Phase 1 in children ages 3-24 months), and NCT03643952 (Phase 2 in Japanese pediatric subjects with cSSTI and bacteremia).
Yes, Daptomycin is also known as Cidecin. A Phase 3 trial (NCT00540072) compared Cidecin (daptomycin) to Rocephin (ceftriaxone) in patients with moderate to severe community-acquired bacterial pneumonia caused by S. pneumoniae.