Back to resultsStudy Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
Primary Purpose
Complicated Skin or Skin Structure Infection
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Vancomycin
Sponsored by
About this trial
This is an interventional health services research trial for Complicated Skin or Skin Structure Infection
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
Sites / Locations
- Heartland I.V. Care
- Heartland I.V. Care
- Heartland I.V. Care
- NationsMed Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Daptomycin
Vancomycin
Arm Description
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
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
Outcomes
Primary Outcome Measures
Time Spent (Minutes) for Home Infusion Therapy
Each participant is counted once per category. Avg=average; Admin=administer.
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
The mean duration in home-infusion antibiotic therapy per participant is presented.
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Each participant is counted once per category.
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
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
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.
Full Information
NCT ID
NCT01175707
First Posted
July 20, 2010
Last Updated
December 3, 2018
Sponsor
Cubist Pharmaceuticals LLC
1. Study Identification
Unique Protocol Identification Number
NCT01175707
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
July 15, 2010 (Actual)
Primary Completion Date
November 17, 2011 (Actual)
Study Completion Date
November 17, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Skin or Skin Structure Infection
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomycin
Arm Type
Experimental
Arm Description
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Primary Outcome Measure Information:
Title
Time Spent (Minutes) for Home Infusion Therapy
Description
Each participant is counted once per category. Avg=average; Admin=administer.
Time Frame
Day 1 up to Day 14
Title
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
Description
The mean duration in home-infusion antibiotic therapy per participant is presented.
Time Frame
Day 1 up to Day 14
Title
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Description
Each participant is counted once per category.
Time Frame
Day 1 up to Day 14
Title
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Time Frame
Day 1 up to Day 14
Title
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
Time Frame
Day 1 up to Day 14
Title
Reasons for Nurse Visits During Home Infusion Therapy
Description
The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.
Time Frame
Day 1 up to Day 14
Title
Reasons for Pharmacist Consultations During Home Infusion Therapy
Description
The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.
Time Frame
Day 1 up to Day 14
Title
Percentage of Treatment Goals Met at End of Therapy
Description
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.
Time Frame
Day 1 up to Day 14
Secondary Outcome Measure Information:
Title
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Description
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.
Time Frame
Day 1 up to Day 14
Title
Mean Number of Interventions Per Participant During Home Infusion Therapy
Description
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.
Time Frame
Day 1 up to Day 14
Title
Number of Intervention Types During Home Infusion Therapy
Description
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.
Time Frame
Day 1 up to Day 14
Title
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Description
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Time Frame
Day 1 up to Day 14
Title
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Description
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
Time Frame
Day 1 up to Day 14
Title
Number of Laboratory Assessment Types During Home Infusion Therapy
Description
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
Time Frame
Day 1 up to Day 14
Title
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Description
Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.
Time Frame
Day 1 up to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Bokesch, MD
Organizational Affiliation
Cubist Pharmaceuticals LLC
Official's Role
Study Director
Facility Information:
Facility Name
Heartland I.V. Care
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48150
Country
United States
Facility Name
Heartland I.V. Care
City
Roseville
State/Province
Minnesota
ZIP/Postal Code
55113
Country
United States
Facility Name
Heartland I.V. Care
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
NationsMed Clinical Research, Inc.
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
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