Clinical trial NCT01175707: Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Complicated Skin or Skin Structure Infection
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Time Spent (Minutes) for Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Reasons for Nurse Visits During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Reasons for Pharmacist Consultations During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Percentage of Treatment Goals Met at End of Therapy
timeFrame: Day 1 up to Day 14
Secondary outcomes:
measure: Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Mean Number of Interventions Per Participant During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Number of Intervention Types During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Number of Laboratory Assessment Types During Home Infusion Therapy
timeFrame: Day 1 up to Day 14
measure: Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
timeFrame: Day 1 up to Day 14
Other outcomes:
Locations:
city: Livonia
country: United States
facility: Heartland I.V. Care
state: Michigan
city: Roseville
country: United States
facility: Heartland I.V. Care
state: Minnesota
city: Pittsburgh
country: United States
facility: Heartland I.V. Care
state: Pennsylvania
city: Stafford
country: United States
facility: NationsMed Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Paula Bokesch, MD
role: STUDY_DIRECTOR
References: