Study Comparing Cubicin With Vancomycin in Treatment of Patients With Complicated Skin and Skin Structure Infections in a Home Infusion Setting - Full Text View

Purpose

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 cSSSI due to Gram-positive bacteria in patients who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting.

Condition	Intervention	Phase
Complicated Skin or Skin Structure Infection	Drug: Daptomycin Drug: Vancomycin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
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

Resource links provided by NLM:

Drug Information available for: Vancomycin Vancomycin hydrochloride Daptomycin

U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:

Evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider [ Time Frame: Day 4; Day 7; Day 14 (if applicable); end of therapy (approximately 7-14 days after treatment begins); 30 days post therapy; 90 days post therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Operational differences associated with receipt of IV medication in a home infusion setting [ Time Frame: Day 4; Day 7; Day 14 (if applicable); end of therapy (approximately 7-14 days after treatment begins); 30 days post therapy; 90 days post therapy ] [ Designated as safety issue: No ]
explore operational differences associated with receiving daptomycin compared to vancomycin in a home infusion setting
Health economics differences associated with receipt of IV medication in a home infusion setting [ Time Frame: Day 4; Day 7; Day 14 (if applicable); end of therapy (approximately 7-14 days after treatment begins); 30 days post therapy; 90 days post therapy ] [ Designated as safety issue: No ]
explore operational differences associated with receiving daptomycin compared to vancomycin in a home infusion setting

Enrollment:	80
Study Start Date:	July 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Daptomycin	Drug: Daptomycin Daptomycin monotherapy - to be administered according to package insert for 7-14 days or longer according to institutional practice if warranted Other Name: Cubicin
Active Comparator: Vancomycin	Drug: Vancomycin Vancomycin monotherapy - to be administered according to prescribing physician's order with duration of treatment modified according to institutional practice if warranted

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 patients who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. Study enrollment will continue until at least 100 patients have been enrolled into each treatment arm. Study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Complicated skin or skin structure infection (cSSSI)
Intravenous vancomycin home infusion ordered for 7-14 days; and

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, cyclosporine, etc. 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;
Patients with known or suspected creatinine clearance (CLcr) <30 mL/min;
In skilled nursing facility;or
In hospice or admission to hospice is planned

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175707

Locations

United States, Michigan
Heartland I.V. Care
Livonia, Michigan, United States, 48150
United States, Minnesota
Heartland I.V. Care
Roseville, Minnesota, United States, 55113
United States, Pennsylvania
Heartland I.V. Care
Pittsburgh, Pennsylvania, United States, 15220
United States, Texas
NationsMed Clinical Research, Inc.
Stafford, Texas, United States, 77477

Sponsors and Collaborators

Cubist Pharmaceuticals

Investigators

Study Director:

Paula Bokesch, MD

Cubist Pharmaceuticals

More Information

No publications provided

Responsible Party:	Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01175707 History of Changes
Other Study ID Numbers:	DAP-4HOME-09-05
Study First Received:	July 20, 2010
Last Updated:	January 12, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Vancomycin
Daptomycin
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013