Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
Stopped early · Phase 4
Conditions studied: Complicated Skin or Skin Structure Infection
In brief
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.
Key facts
- Study ID
- NCT01175707
- Run by
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 80
- Starts
- 2010-07-15
- Expected to finish
- 2011-11-17
- Last updated by the study team
- 2018-12-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Complicated skin or skin structure infection (cSSSI)
- Intravenous vancomycin home infusion ordered for 7-14 days
You may not qualify if…
- 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
Where it is running
- Heartland I.V. Care — Livonia, Michigan, United States
- Heartland I.V. Care — Roseville, Minnesota, United States
- Heartland I.V. Care — Pittsburgh, Pennsylvania, United States
- NationsMed Clinical Research, Inc. — Stafford, Texas, United States
Full record on ClinicalTrials.gov
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