Trial Outcomes & Findings for Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections (NCT NCT01549613)
NCT ID: NCT01549613
Last Updated: 2014-08-01
Results Overview
RDTC cellulitis protocol discharge criteria
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
104 participants
Primary outcome timeframe
Time point at which outcome measure is assessed 30 days from the date of admission.
Results posted on
2014-08-01
Participant Flow
Participant milestones
| Measure |
Standard Treatment With Daptomycin
Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
|
Standard Treatment of Vancomycin
Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
Standard Treatment With Daptomycin
Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
|
Standard Treatment of Vancomycin
Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
Baseline Characteristics
Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
Baseline characteristics by cohort
| Measure |
Standard Treatment With Daptomycin
n=50 Participants
Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
|
Standard Treatment of Vancomycin
n=50 Participants
Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12 • n=5 Participants
|
38 years
STANDARD_DEVIATION 13 • n=7 Participants
|
40 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time point at which outcome measure is assessed 30 days from the date of admission.RDTC cellulitis protocol discharge criteria
Outcome measures
| Measure |
Standard Treatment With Daptomycin
n=50 Participants
Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
|
Standard Treatment of Vancomycin
n=50 Participants
Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
|
|---|---|---|
|
Satisfaction of Discharge Criteria
|
15 participants
Interval -0.58 to 1.98
|
14 participants
|
SECONDARY outcome
Timeframe: Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.Change in lesion area and temperature
Outcome measures
Outcome data not reported
Adverse Events
Standard Treatment With Daptomycin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard Treatment of Vancomycin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Treatment With Daptomycin
n=50 participants at risk
Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
|
Standard Treatment of Vancomycin
n=50 participants at risk
Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
|
|---|---|---|
|
Investigations
hospital readmission
|
2.0%
1/50 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
redman syndrome
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sought treatment of town
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
hives
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
General disorders
scheduled surgery for ovarian cyst
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
General disorders
Returned to pmc for HPT and Diabetes
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Iv infiltrated
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
dog bite
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Red streak
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
Additional Information
George J. Shaw, MD, PhD
University of Cincinnati, Dept. of Emergency Medicine
Phone: 513-558-8098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place