Status:
TERMINATED
Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Complicated Skin or Skin Structure Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a randomized, open-label, multi-center, phase 4 study. The overall goals of this study are to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for ...
Eligibility Criteria
Inclusion
- Complicated skin or skin structure infection (cSSSI)
- Intravenous vancomycin home infusion ordered for 7-14 days
Exclusion
- 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
Key Trial Info
Start Date :
July 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01175707
Start Date
July 15 2010
End Date
November 17 2011
Last Update
December 26 2018
Active Locations (4)
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1
Heartland I.V. Care
Livonia, Michigan, United States, 48150
2
Heartland I.V. Care
Roseville, Minnesota, United States, 55113
3
Heartland I.V. Care
Pittsburgh, Pennsylvania, United States, 15220
4
NationsMed Clinical Research, Inc.
Stafford, Texas, United States, 77477