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

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Skin or Skin Structure Infection

Intervention: Daptomycin (Drug); Vancomycin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Cubist Pharmaceuticals

Official(s) and/or principal investigator(s):
Paula Bokesch, MD, Study Director, Affiliation: Cubist Pharmaceuticals Holdings LLC

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 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Time Spent (Minutes) for Home Infusion Therapy

Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy

Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy

Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy

Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy

Reasons for Nurse Visits During Home Infusion Therapy

Reasons for Pharmacist Consultations During Home Infusion Therapy

Percentage of Treatment Goals Met at End of Therapy

Secondary outcome:

Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy

Mean Number of Interventions Per Participant During Home Infusion Therapy

Number of Intervention Types During Home Infusion Therapy

Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy

Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy

Number of Laboratory Assessment Types During Home Infusion Therapy

Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Heartland I.V. Care, Livonia, Michigan 48150, United States

Heartland I.V. Care, Roseville, Minnesota 55113, United States

Heartland I.V. Care, Pittsburgh, Pennsylvania 15220, United States

NationsMed Clinical Research, Inc., Stafford, Texas 77477, United States

Additional Information

Starting date: July 2010
Last updated: April 28, 2015

Page last updated: August 23, 2015

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