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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01175707
Recruitment Status : Terminated (Business decision)
First Posted : August 5, 2010
Results First Posted : May 13, 2015
Last Update Posted : December 26, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : July 15, 2010
Actual Primary Completion Date : November 17, 2011
Actual Study Completion Date : November 17, 2011

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Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Time Spent (Minutes) for Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    Each participant is counted once per category. Avg=average; Admin=administer.

  2. Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    The mean duration in home-infusion antibiotic therapy per participant is presented.

  3. Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    Each participant is counted once per category.

  4. Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
  5. Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
  6. Reasons for Nurse Visits During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.

  7. Reasons for Pharmacist Consultations During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.

  8. Percentage of Treatment Goals Met at End of Therapy [ Time Frame: Day 1 up to Day 14 ]

    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.



Secondary Outcome Measures :
  1. Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    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.

  2. Mean Number of Interventions Per Participant During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    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.

  3. Number of Intervention Types During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    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.

  4. Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.

  5. Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.

  6. Number of Laboratory Assessment Types During Home Infusion Therapy [ Time Frame: Day 1 up to Day 14 ]
    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

  7. Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant [ Time Frame: Day 1 up to Day 14 ]
    Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175707


Locations
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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 LLC
Investigators
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Study Director: Paula Bokesch, MD Cubist Pharmaceuticals LLC
More Information
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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01175707    
Other Study ID Numbers: 3009-009
DAP-4HOME-09-05 ( Other Identifier: Cubist Study Number )
First Posted: August 5, 2010    Key Record Dates
Results First Posted: May 13, 2015
Last Update Posted: December 26, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes
 Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents