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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

NCT ID: NCT01175707

Last Updated: 2018-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-15

Study Completion Date

2011-11-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Complicated Skin or Skin Structure Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Daptomycin

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

Group Type EXPERIMENTAL

Daptomycin

Intervention Type DRUG

Vancomycin

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

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Interventions

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Daptomycin

Intervention Type DRUG

Vancomycin

Intervention Type DRUG

Other Intervention Names

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Cubicin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Bokesch, MD

Role: STUDY_DIRECTOR

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

Locations

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Heartland I.V. Care

Livonia, Michigan, United States

Site Status

Heartland I.V. Care

Roseville, Minnesota, United States

Site Status

Heartland I.V. Care

Pittsburgh, Pennsylvania, United States

Site Status

NationsMed Clinical Research, Inc.

Stafford, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DAP-4HOME-09-05

Identifier Type: OTHER

Identifier Source: secondary_id

3009-009

Identifier Type: -

Identifier Source: org_study_id