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

• Sponsor: Cubist Pharmaceuticals LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01175707
• Collaborator: (none)
• Enrollment: 80
• Locations: 4
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site: 20
• Patients Per Site Per Month: 1.2

Study Details

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.

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

• Study Type: Interventional
• 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: Jul 15, 2010
• Actual Primary Completion Date: Nov 17, 2011
• Actual Study Completion Date: Nov 17, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time Spent (Minutes) for Home Infusion Therapy [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 [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 [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 [Day 1 up to Day 14]

5. Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy [Day 1 up to Day 14]

6. Reasons for Nurse Visits During Home Infusion Therapy [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Heartland I.V. Care	Livonia	Michigan	United States	48150
2	Heartland I.V. Care	Roseville	Minnesota	United States	55113
3	Heartland I.V. Care	Pittsburgh	Pennsylvania	United States	15220
4	NationsMed Clinical Research, Inc.	Stafford	Texas	United States	77477

Sponsors and Collaborators

• Cubist Pharmaceuticals LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cubist Pharmaceuticals LLC
• ClinicalTrials.gov Identifier: NCT01175707
• Other Study ID Numbers: 3009-009; DAP-4HOME-09-05
• First Posted: Aug 5, 2010
• Last Update Posted: Dec 26, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Infections; Communicable Diseases; Vancomycin; Daptomycin

Study Results

Participant Flow

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Period Title: Overall Study
STARTED	40	40
COMPLETED	36	34
NOT COMPLETED	4	6

Baseline Characteristics

Arm/Group Title	Daptomycin	Vancomycin	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.55 (14.387)	56.78 (19.366)	57.665 (16.8765)
Sex: Female, Male (Count of Participants)
Female	19 47.5%	21 52.5%	40 50%
Male	21 52.5%	19 47.5%	40 50%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Total antibiotic therapy duration	160.7 (326.07)	1430.1 (1331.45)
Total time to administer drug	87.6 (132.66)	1001.7 (696.76)
Avg time per day to administer drug	6.64 (8.221)	127.78 (59.565)
Avg time to admin drug per infusion	6.64 (8.221)	95.81 (23.566)
Total caregiver time to admin drug	261.8 (494.86)	1336 (1527.67)
Avg caregiver time per day to admin drug	16.66 (21.376)	148.66 (174.709)
Avg caregiver time per infusion to admin drug	16.66 (21.376)	124.25 (175.856)
Total nursing time	393.0 (229.34)	404.2 (321.42)
Avg nursing time per visit	73.25 (17.920)	85.80 (23.907)
Avg nursing time per day	73.97 (17.759)	87.79 (25.382)
Total time for pharmacist consultations	60.4 (29.59)	55.3 (35.67)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Mean (Standard Deviation) [Days]	13.0 (6.05)	11.0 (6.11)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Total number of nursing visits	5.8 (3.90)	5.0 (4.18)
Total number of scheduled nursing visits	4.1 (1.91)	4.4 (3.98)
Total number of unscheduled nursing visits	4.91 (4.0)	1.24 (1.0)
Total number of pharmacist consultations	9.6 (4.22)	9.6 (5.79)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	39	40
Number [Participants]	12 30%	15 37.5%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Number [Participants]	40 100%	40 100%

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Laboratory assessment	36	36
Participant/Caregiver teaching	26	29
Site/Catheter care	5	10
Clinical assessment	1	2
Other	28	19

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Development/revision of care plan	25	25
Review of written reports of participant status	16	20
Review of related labs and other studies	38	36
Communication - participant	38	37
Communication - prescriber	26	25
Communication - home care nurse	25	20
Communication - integration of new information	3	4
Other	13	13

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Mean (Standard Deviation) [Percentage of Goals Met]	74.98 (10.842)	75.21 (11.823)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Had at least 1 intervention	9 22.5%	4 10%
Had no intervention	31 77.5%	36 90%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Mean (Standard Deviation) [Interventions]	1.8 (1.30)	1.5 (0.58)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
IV line replacement	2 5%	0 0%
Incision and drainage (wound)	0 0%	1 2.5%
De-clotting procedure	3 7.5%	2 5%
Other	6 15%	2 5%

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Number [Participants]	40 100%	40 100%

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Mean (Standard Deviation) [Assessments]	2.7 (1.19)	2.8 (1.24)

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Serum creatinine	40	40
CPK	39	0
Vancomycin	1	38

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants.

Arm/Group Title	Daptomycin	Vancomycin
Arm/Group 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.
Measure Participants	40	40
Total Drug Costs	2762.37 (1446.140)	107.14 (69.264)
Pharmacy Service and Supplies Costs	641.25 (247.263)	596.25 (278.472)
Nursing Costs	637.63 (404.868)	583.02 (475.495)
Total Heartland Costs	3956.25 (1781.020)	1273.02 (667.673)
Emergency Room (ER) Visit Costs	1660.31 (761.630)	1518 (533.370)
Lost Work Costs	3729.13 (3753.586)	3635.60 (6404.213)

Adverse Events

Arm/Group Title	Daptomycin		Vancomycin
Arm/Group 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.
All Cause Mortality
	Daptomycin		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Daptomycin		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/40 (17.5%)		7/40 (17.5%)
Blood and lymphatic system disorders
Lymphadenopathy	1/40 (2.5%)		0/40 (0%)
Infections and infestations
Infection	2/40 (5%)		3/40 (7.5%)
Cellulitis	2/40 (5%)		1/40 (2.5%)
Device related infection	0/40 (0%)		1/40 (2.5%)
Gangrene	0/40 (0%)		1/40 (2.5%)
Investigations
Blood creatinine increased	0/40 (0%)		1/40 (2.5%)
White blood cell count increased	0/40 (0%)		1/40 (2.5%)
Metabolism and nutrition disorders
Gout	1/40 (2.5%)		0/40 (0%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/40 (2.5%)		0/40 (0%)
Renal and urinary disorders
Haematuria	0/40 (0%)		1/40 (2.5%)
Renal failure acute	1/40 (2.5%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Daptomycin		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/40 (32.5%)		5/40 (12.5%)
Gastrointestinal disorders
Abdominal pain upper	1/40 (2.5%)	1	0/40 (0%)	0
Diarrhoea	0/40 (0%)	0	1/40 (2.5%)	1
General disorders
Asthenia	0/40 (0%)	0	1/40 (2.5%)	1
Catheter site erythema	1/40 (2.5%)	1	0/40 (0%)	0
Catheter site haemorrhage	1/40 (2.5%)	2	0/40 (0%)	0
Device occlusion	1/40 (2.5%)	1	0/40 (0%)	0
Infusion site pain	1/40 (2.5%)	1	0/40 (0%)	0
Medical device complication	2/40 (5%)	2	0/40 (0%)	0
Immune system disorders
Hypersensitivity	1/40 (2.5%)	1	0/40 (0%)	0
Infections and infestations
Abscess	1/40 (2.5%)	1	0/40 (0%)	0
Breast cellulitis	1/40 (2.5%)	1	0/40 (0%)	0
Cellulitis	2/40 (5%)	3	0/40 (0%)	0
Fungal infection	1/40 (2.5%)	1	0/40 (0%)	0
Fungal skin infection	0/40 (0%)	0	1/40 (2.5%)	1
Investigations
Blood creatine phosphokinase increased	1/40 (2.5%)	1	0/40 (0%)	0
Blood pressure increased	0/40 (0%)	0	1/40 (2.5%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/40 (2.5%)	1	0/40 (0%)	0
Skin and subcutaneous tissue disorders
Rash	1/40 (2.5%)	1	3/40 (7.5%)	3
Urticaria	2/40 (5%)	2	0/40 (0%)	0

Limitations/Caveats

The study was terminated prematurely.

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.