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 |
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.
(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.
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
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