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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Terminated; Phase 4

Conditions: Complicated Skin or Skin Structure Infection

Treatments: Drug: Vancomycin; Drug: Daptomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175707

3009-009

DAP-4HOME-09-05 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Daptomycin

Experimental group

Description:

500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted

Treatment:

Drug: Daptomycin

Vancomycin

Active Comparator group

Description:

Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician

Treatment:

Drug: Vancomycin