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



Status:Terminated
Conditions:Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:July 15, 2010
End Date:November 17, 2011

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A Phase 4, Prospective, Randomized, Open-label Study to Compare Use of Cubicin With Vancomycin Administered Intravenously in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Confirmed Gram-positive Bacteria in a Home Infusion Setting

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.

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 the treatment of cSSSI due to Gram-positive bacteria in participants who
are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home
infusion setting. Study objectives include evaluation of clinical and resource utilization
endpoints and economic analysis from the perspective of the home infusion provider.

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
We found this trial at
4
sites
Pittsburgh, Pennsylvania 15220
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Livonia, Michigan 48150
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Livonia, MI
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Roseville, Minnesota 55113
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Roseville, MN
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Stafford, Texas 77477
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Stafford, TX
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