Trial Outcomes & Findings for Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting (NCT NCT01175707)
NCT ID: NCT01175707
Last Updated: 2018-12-26
Results Overview
Each participant is counted once per category. Avg=average; Admin=administer.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Day 1 up to Day 14
Results posted on
2018-12-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
Baseline Characteristics
Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
Baseline characteristics by cohort
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.55 years
STANDARD_DEVIATION 14.387 • n=5 Participants
|
56.78 years
STANDARD_DEVIATION 19.366 • n=7 Participants
|
57.665 years
STANDARD_DEVIATION 16.8765 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
Each participant is counted once per category. Avg=average; Admin=administer.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Time Spent (Minutes) for Home Infusion Therapy
Total antibiotic therapy duration
|
160.7 Minutes
Standard Deviation 326.07
|
1430.1 Minutes
Standard Deviation 1331.45
|
|
Time Spent (Minutes) for Home Infusion Therapy
Total time to administer drug
|
87.6 Minutes
Standard Deviation 132.66
|
1001.7 Minutes
Standard Deviation 696.76
|
|
Time Spent (Minutes) for Home Infusion Therapy
Avg time per day to administer drug
|
6.64 Minutes
Standard Deviation 8.221
|
127.78 Minutes
Standard Deviation 59.565
|
|
Time Spent (Minutes) for Home Infusion Therapy
Avg time to admin drug per infusion
|
6.64 Minutes
Standard Deviation 8.221
|
95.81 Minutes
Standard Deviation 23.566
|
|
Time Spent (Minutes) for Home Infusion Therapy
Total caregiver time to admin drug
|
261.8 Minutes
Standard Deviation 494.86
|
1336 Minutes
Standard Deviation 1527.67
|
|
Time Spent (Minutes) for Home Infusion Therapy
Avg caregiver time per day to admin drug
|
16.66 Minutes
Standard Deviation 21.376
|
148.66 Minutes
Standard Deviation 174.709
|
|
Time Spent (Minutes) for Home Infusion Therapy
Avg caregiver time per infusion to admin drug
|
16.66 Minutes
Standard Deviation 21.376
|
124.25 Minutes
Standard Deviation 175.856
|
|
Time Spent (Minutes) for Home Infusion Therapy
Total nursing time
|
393.0 Minutes
Standard Deviation 229.34
|
404.2 Minutes
Standard Deviation 321.42
|
|
Time Spent (Minutes) for Home Infusion Therapy
Avg nursing time per visit
|
73.25 Minutes
Standard Deviation 17.920
|
85.80 Minutes
Standard Deviation 23.907
|
|
Time Spent (Minutes) for Home Infusion Therapy
Avg nursing time per day
|
73.97 Minutes
Standard Deviation 17.759
|
87.79 Minutes
Standard Deviation 25.382
|
|
Time Spent (Minutes) for Home Infusion Therapy
Total time for pharmacist consultations
|
60.4 Minutes
Standard Deviation 29.59
|
55.3 Minutes
Standard Deviation 35.67
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
The mean duration in home-infusion antibiotic therapy per participant is presented.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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 Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
|
13.0 Days
Standard Deviation 6.05
|
11.0 Days
Standard Deviation 6.11
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
Each participant is counted once per category.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Total number of nursing visits
|
5.8 Visits or Consultations per Participant
Standard Deviation 3.90
|
5.0 Visits or Consultations per Participant
Standard Deviation 4.18
|
|
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Total number of scheduled nursing visits
|
4.1 Visits or Consultations per Participant
Standard Deviation 1.91
|
4.4 Visits or Consultations per Participant
Standard Deviation 3.98
|
|
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Total number of unscheduled nursing visits
|
4.91 Visits or Consultations per Participant
Standard Deviation 4.0
|
1.24 Visits or Consultations per Participant
Standard Deviation 1.0
|
|
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Total number of pharmacist consultations
|
9.6 Visits or Consultations per Participant
Standard Deviation 4.22
|
9.6 Visits or Consultations per Participant
Standard Deviation 5.79
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: 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.
Outcome measures
| Measure |
Daptomycin
n=39 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
|
12 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
|
40 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Reasons for Nurse Visits During Home Infusion Therapy
Laboratory assessment
|
36 Reason Cited
|
36 Reason Cited
|
|
Reasons for Nurse Visits During Home Infusion Therapy
Participant/Caregiver teaching
|
26 Reason Cited
|
29 Reason Cited
|
|
Reasons for Nurse Visits During Home Infusion Therapy
Site/Catheter care
|
5 Reason Cited
|
10 Reason Cited
|
|
Reasons for Nurse Visits During Home Infusion Therapy
Clinical assessment
|
1 Reason Cited
|
2 Reason Cited
|
|
Reasons for Nurse Visits During Home Infusion Therapy
Other
|
28 Reason Cited
|
19 Reason Cited
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Other
|
13 Reason Cited
|
13 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Development/revision of care plan
|
25 Reason Cited
|
25 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Review of written reports of participant status
|
16 Reason Cited
|
20 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Review of related labs and other studies
|
38 Reason Cited
|
36 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Communication - participant
|
38 Reason Cited
|
37 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Communication - prescriber
|
26 Reason Cited
|
25 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Communication - home care nurse
|
25 Reason Cited
|
20 Reason Cited
|
|
Reasons for Pharmacist Consultations During Home Infusion Therapy
Communication - integration of new information
|
3 Reason Cited
|
4 Reason Cited
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
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.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Percentage of Treatment Goals Met at End of Therapy
|
74.98 Percentage of Goals Met
Standard Deviation 10.842
|
75.21 Percentage of Goals Met
Standard Deviation 11.823
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
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.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Had at least 1 intervention
|
9 Participants
|
4 Participants
|
|
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Had no intervention
|
31 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
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.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Mean Number of Interventions Per Participant During Home Infusion Therapy
|
1.8 Interventions
Standard Deviation 1.30
|
1.5 Interventions
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants
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.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Number of Intervention Types During Home Infusion Therapy
IV line replacement
|
2 participants
|
0 participants
|
|
Number of Intervention Types During Home Infusion Therapy
Incision and drainage (wound)
|
0 participants
|
1 participants
|
|
Number of Intervention Types During Home Infusion Therapy
De-clotting procedure
|
3 participants
|
2 participants
|
|
Number of Intervention Types During Home Infusion Therapy
Other
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
|
40 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
|
2.7 Assessments
Standard Deviation 1.19
|
2.8 Assessments
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
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
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Number of Laboratory Assessment Types During Home Infusion Therapy
Serum creatinine
|
40 Assessments
|
40 Assessments
|
|
Number of Laboratory Assessment Types During Home Infusion Therapy
CPK
|
39 Assessments
|
0 Assessments
|
|
Number of Laboratory Assessment Types During Home Infusion Therapy
Vancomycin
|
1 Assessments
|
38 Assessments
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: All study participants.
Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.
Outcome measures
| Measure |
Daptomycin
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Total Drug Costs
|
2762.37 US Dollars
Standard Deviation 1446.140
|
107.14 US Dollars
Standard Deviation 69.264
|
|
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Pharmacy Service and Supplies Costs
|
641.25 US Dollars
Standard Deviation 247.263
|
596.25 US Dollars
Standard Deviation 278.472
|
|
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Nursing Costs
|
637.63 US Dollars
Standard Deviation 404.868
|
583.02 US Dollars
Standard Deviation 475.495
|
|
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Total Heartland Costs
|
3956.25 US Dollars
Standard Deviation 1781.020
|
1273.02 US Dollars
Standard Deviation 667.673
|
|
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Emergency Room (ER) Visit Costs
|
1660.31 US Dollars
Standard Deviation 761.630
|
1518 US Dollars
Standard Deviation 533.370
|
|
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Lost Work Costs
|
3729.13 US Dollars
Standard Deviation 3753.586
|
3635.60 US Dollars
Standard Deviation 6404.213
|
Adverse Events
Daptomycin
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Vancomycin
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daptomycin
n=40 participants at risk
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
n=40 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infection
|
5.0%
2/40
|
7.5%
3/40
|
|
Infections and infestations
Cellulitis
|
5.0%
2/40
|
2.5%
1/40
|
|
Infections and infestations
Device related infection
|
0.00%
0/40
|
2.5%
1/40
|
|
Infections and infestations
Gangrene
|
0.00%
0/40
|
2.5%
1/40
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40
|
2.5%
1/40
|
|
Renal and urinary disorders
Renal failure acute
|
2.5%
1/40
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.5%
1/40
|
0.00%
0/40
|
|
Investigations
Blood creatinine increased
|
0.00%
0/40
|
2.5%
1/40
|
|
Investigations
White blood cell count increased
|
0.00%
0/40
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Gout
|
2.5%
1/40
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40
|
0.00%
0/40
|
Other adverse events
| Measure |
Daptomycin
n=40 participants at risk
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
n=40 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Catheter site erythema
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Catheter site haemorrhage
|
2.5%
1/40 • Number of events 2
|
0.00%
0/40
|
|
General disorders
Device occlusion
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Infusion site pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Medical device complication
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Immune system disorders
Hypersensitivity
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Abscess
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Breast cellulitis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Cellulitis
|
5.0%
2/40 • Number of events 3
|
0.00%
0/40
|
|
Infections and infestations
Fungal infection
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Blood pressure increased
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 1
|
7.5%
3/40 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Phone: 781-860-8318
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER