Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

• Status: Terminated
• Trial end date: 2011-11-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Daptomycin; Vancomycin

Criteria

Inclusion Criteria:

• Complicated skin or skin structure infection (cSSSI)

• Intravenous vancomycin home infusion ordered for 7-14 days

Exclusion Criteria:

• Pregnant or lactating female

• Concurrently receiving other systemic antibiotics with gram positive activity

• Known or suspected allergy or hypersensitivity to daptomycin or vancomycin

• Known or suspected vancomycin-resistant enterococci (VRE)

• Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection

• Known or suspected human immunodeficiency virus (HIV), cancer, or autoimmune disease such as lupus

• Receiving systemic concomitant immunosuppressive agents such as chemotherapy, corticosteroids, tacrolimus, sirolimus, or cyclosporine, during the duration of the study

• Requirement for non-study gram positive systemic antibiotics

• Known to be allergic or intolerant to intravenous vancomycin or daptomycin

• Participants with known or suspected creatinine clearance (CLcr) < 30 milliliters per minute (mL/min)

• In skilled nursing facility

• In hospice or admission to hospice is planned