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

ID: NCT01175707
Status: Terminated
Phase: Phase 4
Start Date: July 01, 2010
First Submitted: July 20, 2010
Last Updated: January 05, 2016
Results: Available
Success Rate: 87%
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: United States
Conditions: Complicated Skin or Skin Structure Infection
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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.
Condition or disease Intervention/treatment Phase

Complicated Skin or Skin Structure Infection
Drug: Daptomycin
Other Names
Cubicin
Drug: Vancomycin
Other Names
Phase 4

Tracking Information

First Submitted DateJuly 20, 2010
Last Update Posted DateJanuary 05, 2016
Start DateJuly 01, 2010
Actual Completion DateNovember 01, 2011
Primary Completion DateNovember 01, 2011
Results First Submitted DateApril 05, 2013
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

  • 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.

  • 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.

  • Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy [Time Frame: Day 1 up to Day 14]

  • Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy [Time Frame: Day 1 up to Day 14]

  • 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.

  • 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.

  • 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.

Original Primary Outcome Measures

  • 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.

  • 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.

  • 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.

  • Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy

  • Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy

  • Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy

    Each participant is counted once per category.

  • Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy

    The mean duration in home-infusion antibiotic therapy per participant is presented.

  • Time Spent (Minutes) for Home Infusion Therapy

    Each participant is counted once per category. Avg=average; Admin=administer.

Current Secondary Outcome Measures

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

Original Secondary Outcome Measures

  • 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.

  • 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

  • Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy

    Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.

  • Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy

    Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.

  • 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.

  • 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 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.

Study Design

Brief TitleStudy Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
Official TitleA 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
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.

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
80
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None
Primary Purpose
Health Services Research
Conditions
Complicated Skin or Skin Structure Infection
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Daptomycin

Other Names
Cubicin
Drug: Vancomycin

Other Names
Study Groups/Cohorts
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

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

Study Arms
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

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

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
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

Recruitment Information

Recruitment Status:Terminated
Enrollment80
Completion DateNovember 01, 2011
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01175707
Other Study ID Numbers
3009-009
DAP-4HOME-09-05
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Paula Bokesch, MD
Cubist Pharmaceuticals LLC

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
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.
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.

Participant Flow: Overall

DaptomycinVancomycin
Started4040
Completed3634
Not Completed46
Adverse Event46

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants

Reporting Groups

TitleDescription
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.
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.
Total
Total of all reporting groups

Baseline Measures

DaptomycinVancomycinTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
404080
404080
Age
Units: years - Mean (Standard Deviation)
Participants Analyzed
404080
58.55 (14.387)56.78 (19.366)57.665 (16.8765)
Gender
Units: participants - Number
Participants Analyzed
404080
Female192140
Male211940

Outcome Measures

1. Primary: Time Spent (Minutes) for Home Infusion Therapy

Measure Type
Primary
Measure Title
Time Spent (Minutes) for Home Infusion Therapy
Measure Description
Each participant is counted once per category. Avg=average; Admin=administer.
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Time Spent (Minutes) for Home Infusion Therapy
Units: Minutes - Mean (Standard Deviation)
Avg caregiver time per day to admin drug16.66 (21.376)148.66 (174.709)
Avg caregiver time per infusion to admin drug16.66 (21.376)124.25 (175.856)
Avg nursing time per day73.97 (17.759)87.79 (25.382)
Avg nursing time per visit73.25 (17.920)85.80 (23.907)
Avg time per day to administer drug6.64 (8.221)127.78 (59.565)
Avg time to admin drug per infusion6.64 (8.221)95.81 (23.566)
Total antibiotic therapy duration160.7 (326.07)1430.1 (1331.45)
Total caregiver time to admin drug261.8 (494.86)1336 (1527.67)
Total nursing time393.0 (229.34)404.2 (321.42)
Total time for pharmacist consultations60.4 (29.59)55.3 (35.67)
Total time to administer drug87.6 (132.66)1001.7 (696.76)

2. Primary: Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy

Measure Type
Primary
Measure Title
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
Measure Description
The mean duration in home-infusion antibiotic therapy per participant is presented.
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
Units: Days - Mean (Standard Deviation)
13.0 (6.05)11.0 (6.11)

3. Primary: Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy

Measure Type
Primary
Measure Title
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Measure Description
Each participant is counted once per category.
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Units: Visits or Consultations per Participant - Mean (Standard Deviation)
Total number of nursing visits5.8 (3.90)5.0 (4.18)
Total number of pharmacist consultations9.6 (4.22)9.6 (5.79)
Total number of scheduled nursing visits4.1 (1.91)4.4 (3.98)
Total number of unscheduled nursing visits4.91 (4.0)1.24 (1.0)

4. Primary: Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy

Measure Type
Primary
Measure Title
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Measure Description
Not Available
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of Participants Analyzed based on number of participants with at least one nurse visit/pharmacist consultation within each treatment group results in 39 participants analyzed for the Daptomycin ARM group for this Outcome Measure.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
3940
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Units: Participants - Number
1215

5. Primary: Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy

Measure Type
Primary
Measure Title
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
Measure Description
Not Available
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
Units: Participants - Number
4040

6. Primary: Reasons for Nurse Visits During Home Infusion Therapy

Measure Type
Primary
Measure Title
Reasons for Nurse Visits During Home Infusion Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Reasons for Nurse Visits During Home Infusion Therapy
Units: Reason Cited - Number
Clinical assessment12
Laboratory assessment3636
Other2819
Participant/Caregiver teaching2629
Site/Catheter care510

7. Primary: Reasons for Pharmacist Consultations During Home Infusion Therapy

Measure Type
Primary
Measure Title
Reasons for Pharmacist Consultations During Home Infusion Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Reasons for Pharmacist Consultations During Home Infusion Therapy
Units: Reason Cited - Number
Communication - home care nurse2520
Communication - integration of new information34
Communication - participant3837
Communication - prescriber2625
Development/revision of care plan2525
Other1313
Review of related labs and other studies3836
Review of written reports of participant status1620

8. Primary: Percentage of Treatment Goals Met at End of Therapy

Measure Type
Primary
Measure Title
Percentage of Treatment Goals Met at End of Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Percentage of Treatment Goals Met at End of Therapy
Units: Percentage of Goals Met - Mean (Standard Deviation)
74.98 (10.842)75.21 (11.823)

9. Secondary: Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy

Measure Type
Secondary
Measure Title
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Units: Participants - Number
Had at least 1 intervention94
Had no intervention3136

10. Secondary: Mean Number of Interventions Per Participant During Home Infusion Therapy

Measure Type
Secondary
Measure Title
Mean Number of Interventions Per Participant During Home Infusion Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Mean Number of Interventions Per Participant During Home Infusion Therapy
Units: Interventions - Mean (Standard Deviation)
1.8 (1.30)1.5 (0.58)

11. Secondary: Number of Intervention Types During Home Infusion Therapy

Measure Type
Secondary
Measure Title
Number of Intervention Types During Home Infusion Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Number of Intervention Types During Home Infusion Therapy
Units: participants - Number
De-clotting procedure32
Incision and drainage (wound)01
IV line replacement20
Other62

12. Secondary: Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy

Measure Type
Secondary
Measure Title
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Measure Description
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Units: Participants - Number
4040

13. Secondary: Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy

Measure Type
Secondary
Measure Title
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Measure Description
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
Time Frame
Day 1 up to Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Units: Assessments - Mean (Standard Deviation)
2.7 (1.19)2.8 (1.24)

14. Secondary: Number of Laboratory Assessment Types During Home Infusion Therapy

Measure Type
Secondary
Measure Title
Number of Laboratory Assessment Types During Home Infusion Therapy
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Number of Laboratory Assessment Types During Home Infusion Therapy
Units: Assessments - Number
CPK390
Serum creatinine4040
Vancomycin138

15. Secondary: Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant

Measure Type
Secondary
Measure Title
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Measure 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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants.

Reporting Groups

TitleDescription
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.
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.

Outcome Measures

DaptomycinVancomycin
Participants Analyzed
Units: Participants
4040
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Units: US Dollars - Mean (Standard Deviation)
Emergency Room (ER) Visit Costs1660.31 (761.630)1518 (533.370)
Lost Work Costs3729.13 (3753.586)3635.60 (6404.213)
Nursing Costs637.63 (404.868)583.02 (475.495)
Pharmacy Service and Supplies Costs641.25 (247.263)596.25 (278.472)
Total Drug Costs2762.37 (1446.140)107.14 (69.264)
Total Heartland Costs3956.25 (1781.020)1273.02 (667.673)

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
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.
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.

Serious Adverse Events

DaptomycinVancomycin
Total, serious adverse events
No. of participants affected / at risk7/40 (0.00%)7/40 (0.00%)
Lymphadenopathy
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Infection
No. of participants affected / at risk2/40 (0.00%)3/40 (0.00%)
Cellulitis
No. of participants affected / at risk2/40 (0.00%)1/40 (0.00%)
Device related infection
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Gangrene
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Blood creatinine increased
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
White blood cell count increased
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Gout
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Pain in extremity
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Haematuria
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Renal failure acute
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
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.
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.

Other Adverse Events

DaptomycinVancomycin
Total, other adverse events
No. of participants affected / at risk13/40 (0.00%)5/40 (0.00%)
Abdominal pain upper
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Diarrhoea
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Asthenia
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Catheter site erythema
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Catheter site haemorrhage
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Device occlusion
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Infusion site pain
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Medical device complication
No. of participants affected / at risk2/40 (0.00%)0/40 (0.00%)
Hypersensitivity
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Abscess
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Breast cellulitis
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Cellulitis
No. of participants affected / at risk2/40 (0.00%)0/40 (0.00%)
Fungal infection
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Fungal skin infection
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Blood creatine phosphokinase increased
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Blood pressure increased
No. of participants affected / at risk0/40 (0.00%)1/40 (0.00%)
Dyspnoea
No. of participants affected / at risk1/40 (0.00%)0/40 (0.00%)
Rash
No. of participants affected / at risk1/40 (0.00%)3/40 (0.00%)
Urticaria
No. of participants affected / at risk2/40 (0.00%)0/40 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.
The first publication is initiated by Cubist. If First Publication not published within 1 year of Study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Vice President, Clinical Research
Cubist Pharmaceuticals
781-860-8318