Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

Phase 3

Completed

• Conditions: Infections
• Interventions: Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs); Drug: Daptomycin

• Registration Number: NCT01184872
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-18
• Study Start: 2010-03
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-03-22
• Results First Submitted QC: 2012-03-22
• Results First Posted: 2012-04-18
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin or Semi-Synthetic Penicillins (SSPs)	Vancomycin or Semi-Synthetic Penicillins (SSPs)	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.
Daptomycin	Daptomycin	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit	Baseline and 7 to 14 days after end of therapy	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit	Baseline and 7 to 14 days after end of therapy	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.
Duration of Treatment (Intravenous)	Up to 28 days	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.
Duration of Treatment (Intravenous and Oral)	Up to 28 days	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.
Number of Patients With Adverse Events, Serious Adverse Events and Death	Continuously from baseline up to 28 days after end of antibiotic treatment.

Trial Locations

Locations (3)

Novartis Investigative Site; 🇪🇸 Seville, Spain

Novartis Investigative Site (2); 🇷🇺 Saint Petersburg, Russian Federation

Novartis Investigative Site (1); 🇪🇸 Madrid, Spain