The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
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.
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Bochum, Germany
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
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.
Time frame: Baseline and 7 to 14 days after end of therapy
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.
Time frame: Baseline and 7 to 14 days after end of therapy
Duration of Treatment (Intravenous)
Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
Time frame: Up to 28 days
Duration of Treatment (Intravenous and Oral)
Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
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Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Homburg, Germany
Novartis Investigative Site
Magdeburg, Germany
Novartis Investigative Site
Mannheim, Germany
Novartis Investigative Site
Münster, Germany
Novartis Investigative Site
Tübingen, Germany
Novartis Investigative Site
Pisa, Italy
...and 7 more locations
Time frame: Up to 28 days
Number of Patients With Adverse Events, Serious Adverse Events and Death
Time frame: Continuously from baseline up to 28 days after end of antibiotic treatment.