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

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

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.

Study Overview

• Status: Terminated
• Conditions: Complicated Skin or Skin Structure Infection
• Intervention / Treatment: Drug: Vancomycin; Drug: Daptomycin

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Daptomycin; Other Names: Cubicin
Active Comparator: 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	Drug: Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent (Minutes) for Home Infusion Therapy	Each participant is counted once per category. Avg=average; Admin=administer.	Day 1 up to Day 14
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy	The mean duration in home-infusion antibiotic therapy per participant is presented.	Day 1 up to Day 14
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy	Each participant is counted once per category.	Day 1 up to Day 14
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy		Day 1 up to Day 14
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy		Day 1 up to Day 14
Reasons for Nurse Visits During Home Infusion Therapy	The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.	Day 1 up to Day 14
Reasons for Pharmacist Consultations During Home Infusion Therapy	The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.	Day 1 up to Day 14
Percentage of Treatment Goals Met at End of Therapy	Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic. Each participant's percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants' percentage of goals met by arm.	Day 1 up to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy	Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.	Day 1 up to Day 14
Mean Number of Interventions Per Participant During Home Infusion Therapy	Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.	Day 1 up to Day 14
Number of Intervention Types During Home Infusion Therapy	There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.	Day 1 up to Day 14
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy	Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.	Day 1 up to Day 14
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy	Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.	Day 1 up to Day 14
Number of Laboratory Assessment Types During Home Infusion Therapy	There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough	Day 1 up to Day 14
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant	Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.	Day 1 up to Day 14

Collaborators and Investigators

• Sponsor: Cubist Pharmaceuticals LLC
• Investigators: Study Director: Paula Bokesch, MD, Cubist Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2010
• Primary Completion (Actual): November 17, 2011
• Study Completion (Actual): November 17, 2011

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Daptomycin
• Other Study ID Numbers: 3009-009; DAP-4HOME-09-05 (Other Identifier: Cubist Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf