Cubicin Clinical Trials and Studies
Cubicin Information
Cubicin Clinical Trials and Studies
Complicated Skin and Skin Structure Infections:
Adult patients with clinically documented complicated skin and skin structure infections were enrolled in 2 randomized, multinational, multicenter, investigator-blinded studies comparing Cubicin (4 mg/kg IV q24h) with either vancomycin (1 g IV q12h) or a semi-synthetic penicillin (ie,nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4-12 g IV per day). Patients known to have bacteremia at baseline were excluded. Patients with creatinine clearance between 30-70 mL/min were to receive a lower dose of Cubicin (daptomycin) as specified in the protocol; however, the majority of patients in this subpopulation did not have the dose of Cubicin (daptomycin) adjusted. Patients could switch to oral therapy after a minimum of 4 days of IV treatment if clinical improvement was demonstrated.
One study was conducted primarily in the United States and South Africa (study 9801), and the second (study 9901) was conducted at non-U.S.sites only. Both studies were similar in design but differed in patient characteristics, including history of diabetes and peripheral vascular disease. There were a total of 534 patients treated with Cubicin (daptomycin) and 558 treated with comparator in the 2 studies. The majority (89.7%) of patients received IV medication exclusively. The efficacy endpoints in both studies were the clinical success rates in the intent-to-treat (ITT) population and in the clinically evaluable (CE) population. In study 9801,clinical success rates in the ITT population were 62.5% (165/264) in patients treated with Cubicin (daptomycin) and 60.9% (162/266) in patients treated with comparator drugs. Clinical success rates in the CE population were 76.0% (158/208) in patients treated with daptomycin and 76.7% (158/206) in patients treated with comparator drugs. In study 9901, clinical success rates in the ITT population were 80.4% (217/270) in patients treated with Cubicin (daptomycin) and 80.5% (235/292) in patients treated with comparator drugs. Clinical success rates in the CE population were 89.9% (214/238) in patients treated with Cubicin (daptomycin) and 90.4% (226/250) in patients treated with comparator drugs.
Cubicin Information
