Trial Outcomes & Findings for Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (NCT NCT02961764)
NCT ID: NCT02961764
Last Updated: 2020-04-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
313 participants
Primary outcome timeframe
44 Days
Results posted on
2020-04-10
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
153
|
|
Overall Study
COMPLETED
|
121
|
128
|
|
Overall Study
NOT COMPLETED
|
39
|
25
|
Reasons for withdrawal
| Measure |
Usual Care
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
35
|
24
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Baseline characteristics by cohort
| Measure |
Usual Care
n=156 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=153 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Customized
20-29 years
|
28 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Age, Customized
30-39 years
|
31 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Age, Customized
40-49 years
|
25 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Age, Customized
50-59 years
|
37 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Age, Customized
60-69 years
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Age, Customized
70-79 years
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Age, Customized
80-89 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Customized
90-98 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=93 Participants
|
99 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
223 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
89 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
180 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Patient chose not to answer
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.
Outcome measures
| Measure |
Usual Care
n=156 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=153 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Hospital Admission Rate at Initial Episode of Care
Yes
|
60 Participants
|
27 Participants
|
|
Hospital Admission Rate at Initial Episode of Care
No
|
96 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: FAS population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Total Admitted Hospital Days
|
2.3 Days
Standard Deviation 3.74
|
1.2 Days
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Initial Care: 14 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.
Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
Outcome measures
| Measure |
Usual Care
n=156 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=153 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
|
7.7 Hours
Standard Deviation 9.09
|
6.1 Hours
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Number of all major surgical interventions unexpected or expected that required operating room time
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
No Surgeries
|
107 Participants
|
106 Participants
|
|
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Any Surgeries
|
38 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Infection-related Total Admitted Hospital Days
|
2.0 Days
Standard Deviation 3.06
|
1.0 Days
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Infection-related Hospitalizations
None
|
85 Participants
|
110 Participants
|
|
Number of Participants With Infection-related Hospitalizations
Any
|
60 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit
Admission to ICU
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Follow-up: 30 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Infection-related Emergency Department (ED) Visits
|
22 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Infection-related Outpatient Healthcare Visits
|
57 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Peripheral IV
|
93 Participants
|
141 Participants
|
|
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Central line
|
0 Participants
|
0 Participants
|
|
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
PICC line
|
1 Participants
|
1 Participants
|
|
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
No Line
|
143 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
Outcome measures
| Measure |
Usual Care
n=145 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=141 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
1 occurence
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 44 DaysPopulation: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion
Outcome measures
| Measure |
Usual Care
n=156 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=153 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Overall Health
Very good
|
38 Participants
|
31 Participants
|
|
Patient Satisfaction With Care: Overall Health
Excellent
|
12 Participants
|
22 Participants
|
|
Patient Satisfaction With Care: Overall Health
Good
|
35 Participants
|
40 Participants
|
|
Patient Satisfaction With Care: Overall Health
Fair
|
30 Participants
|
23 Participants
|
|
Patient Satisfaction With Care: Overall Health
Poor
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Wait in Emergency Room
|
7.8 scores on a scale
Standard Deviation 2.63
|
8.3 scores on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Hospitalization
Yes
|
63 Participants
|
27 Participants
|
|
Patient Satisfaction With Care: Hospitalization
No
|
56 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 63 and 27 patients had a hospital stay in the usual care group and new critical pathway group, respectively.
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Outcome measures
| Measure |
Usual Care
n=63 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=27 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Satisfaction With Hospital Stay
|
8.2 Scores on a Scale
Standard Deviation 2.19
|
8.0 Scores on a Scale
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Hospital stay interfered with work/school
|
11 Participant
|
8 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Stay got in way of daily normal activities
|
11 Participant
|
10 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Stay got in the way of providing care to others
|
8 Participant
|
8 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Hospital stay was expensive
|
2 Participant
|
6 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Did not provide adequate monitoring by providers
|
3 Participant
|
1 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Did not provide well trained healthcare providers
|
3 Participant
|
0 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Hospital stay made me feel worse
|
3 Participant
|
0 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Hospital stay made me feel concerned
|
14 Participant
|
7 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Hospital stay was uncomfortable
|
11 Participant
|
5 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Hospital stay disrupted my sleep
|
12 Participant
|
6 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Other
|
7 Participant
|
2 Participant
|
|
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
I was not dissatisfied with my hospital stay
|
33 Participant
|
12 Participant
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Yes
|
87 Participants
|
119 Participants
|
|
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
No
|
32 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 86 and 119 patients answered this question in the usual care group \& new critical pathway group, respectively.
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Outcome measures
| Measure |
Usual Care
n=86 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=119 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
|
8.7 Scores on a Scale
Standard Deviation 2.16
|
9.0 Scores on a Scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Other
|
4 Participants
|
8 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Allowed me to return to work/school
|
37 Participants
|
50 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Allowed me to return to daily normal activities
|
48 Participants
|
81 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Allowed me to return to providing care to others
|
38 Participants
|
52 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
IV antibiotic therapy was affordable
|
29 Participants
|
45 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Administered at appointments that I could schedule
|
4 Participants
|
11 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Administered quickly once arrived at appt
|
4 Participants
|
17 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Administered at setting that had convenient hours
|
3 Participants
|
16 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Ensured regular monitoring by healthcare providers
|
26 Participants
|
29 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Administered by skilled healthcare providers
|
51 Participants
|
58 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
IV antibiotic therapy made me feel better
|
55 Participants
|
80 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Allowed to receive care for skin infection at home
|
4 Participants
|
10 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Convenient to administer by self/caregiver at home
|
2 Participants
|
4 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Not satisfied with receiving IV antibiotic therapy
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Got in the way of work/school
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Got in way of performing daily normal activities
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Got in the way of providing care to others
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
IV antibiotic therapy was expensive
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Required me to make appointments
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Administered at healthcare setting w/limited hours
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Required traveling to and from appointments
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Required to wait to be seen by provider
|
1 Participants
|
2 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
IV antibiotic therapy took too long to administer
|
1 Participants
|
3 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Required having a PICC or central line inserted
|
2 Participants
|
2 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Caused an IV site infection
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
IV antibiotic therapy made me feel worse
|
2 Participants
|
2 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Not adequately monitored by healthcare providers
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Not administered by skilled healthcare providers
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
IV antibiotic therapy made me feel concerned
|
2 Participants
|
2 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Required a nurse/healthcare worker coming to home
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Required administration to self/caregiver at home
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Other
|
4 Participants
|
1 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Not dissatisfied w/receiving IV antibiotic therapy
|
72 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 87 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=87 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=118 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
None of the time
|
66 Participants
|
94 Participants
|
|
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
A little of the time
|
6 Participants
|
10 Participants
|
|
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Some of the time
|
6 Participants
|
11 Participants
|
|
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Most of the time
|
5 Participants
|
1 Participants
|
|
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
All of the time
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 87 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=87 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=118 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
None of the time
|
62 Participants
|
80 Participants
|
|
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
A little of the time
|
8 Participants
|
19 Participants
|
|
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Some of the time
|
8 Participants
|
12 Participants
|
|
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Most of the time
|
5 Participants
|
3 Participants
|
|
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
All of the time
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 85 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Outcome measures
| Measure |
Usual Care
n=85 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=118 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
|
8.4 Scores on a scale
Standard Deviation 2.36
|
9.0 Scores on a scale
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: Day 14Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 85 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Outcome measures
| Measure |
Usual Care
n=85 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=118 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
|
8.6 Scores on a Scale
Standard Deviation 1.87
|
8.8 Scores on a Scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 86 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=86 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=118 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
Less than 15 minutes
|
7 Participants
|
19 Participants
|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
16 - 30 minutes
|
5 Participants
|
17 Participants
|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
31 - 60 minutes
|
2 Participants
|
4 Participants
|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
61 - 90 minutes
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
More than 90 minutes
|
2 Participants
|
0 Participants
|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
I did not need to travel to my appointments
|
68 Participants
|
77 Participants
|
|
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
I don't remember
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 86 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=86 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=118 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
Less than 15 minutes
|
4 Participants
|
17 Participants
|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
16 - 30 minutes
|
7 Participants
|
10 Participants
|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
31 - 60 minutes
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
61 - 90 minutes
|
3 Participants
|
2 Participants
|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
More than 90 minutes
|
2 Participants
|
8 Participants
|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
I did not need to wait for my appointments
|
67 Participants
|
75 Participants
|
|
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
I don't remember
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 116 and 123 patients answered this question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=116 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=123 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
Overnight hospital stay for one or more nights
|
42 Participants
|
17 Participants
|
|
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
Outpatient care: Brief hospital visit w/no stay
|
74 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=124 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
To avoid hospital stay for 1 or more nights
|
52 Participants
|
91 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
To allow me to return to work/school
|
37 Participants
|
44 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
To return to performing daily normal living
|
48 Participants
|
65 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
To allow me to return to providing care to others
|
27 Participants
|
36 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Outpatient care would be more affordable
|
21 Participants
|
38 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Outpatient care would be more convenient
|
43 Participants
|
64 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
To ensure monitoring by healthcare providers
|
10 Participants
|
22 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Administered by skilled healthcare providers
|
17 Participants
|
27 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Other
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
I would not prefer outpatient care
|
38 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 117 and 121 patients answered this survey question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=117 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=121 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Regimen 1
|
65 Participants
|
107 Participants
|
|
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Regimen 2
|
14 Participants
|
6 Participants
|
|
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Regimen 3
|
38 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 117 and 123 patients answered this survey question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=117 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=123 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
About 30 minutes or less
|
73 Participants
|
87 Participants
|
|
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
About 1 hour
|
28 Participants
|
32 Participants
|
|
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
About 1.5 to 2 hours
|
13 Participants
|
3 Participants
|
|
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
About 3 hours or longer
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 115 and 123 patients answered this survey question in the usual care group \& new critical pathway group, respectively.
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Outcome measures
| Measure |
Usual Care
n=115 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=123 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Satisfaction With Care: Find Value in a Physician
Definitely not
|
13 Participants
|
5 Participants
|
|
Patient Satisfaction With Care: Find Value in a Physician
Probably not
|
13 Participants
|
8 Participants
|
|
Patient Satisfaction With Care: Find Value in a Physician
Probably so
|
38 Participants
|
37 Participants
|
|
Patient Satisfaction With Care: Find Value in a Physician
Definitely so
|
51 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 123 patients provided any survey data in the usual care group and the new critical pathway group; 53 and 48 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 61 and 56 were employed.
Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=123 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Absenteeism
|
17.4 Percentage
Standard Deviation 31.96
|
18.9 Percentage
Standard Deviation 33.49
|
|
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Impairment while working
|
14.5 Percentage
Standard Deviation 24.14
|
10.8 Percentage
Standard Deviation 22.30
|
|
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Overall work impairment
|
21.3 Percentage
Standard Deviation 29.04
|
16.4 Percentage
Standard Deviation 26.82
|
|
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Activity impairment
|
24.2 Percentage
Standard Deviation 34.06
|
15.9 Percentage
Standard Deviation 28.88
|
SECONDARY outcome
Timeframe: Day 14Population: FAS population. 119 and 122 patients provided any and all survey data in the usual care group and the new critical pathway group, respectively.
The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score \[PCS\] and mental component summary score \[MCS\]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.
Outcome measures
| Measure |
Usual Care
n=119 Participants
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=122 Participants
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Mental Health Component Score
|
51.2 Score on a Scale
Standard Deviation 10.36
|
52.6 Score on a Scale
Standard Deviation 9.63
|
|
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Physical Health Component Score
|
46.4 Score on a Scale
Standard Deviation 10.36
|
47.8 Score on a Scale
Standard Deviation 9.39
|
Adverse Events
Usual Care
Serious events: 11 serious events
Other events: 4 other events
Deaths: 2 deaths
New Critical Pathway
Serious events: 16 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Usual Care
n=156 participants at risk
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=153 participants at risk
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Infections and infestations
CELLULITIS
|
1.3%
2/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
5.2%
8/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
SKIN INFECTION
|
1.3%
2/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
BRONCHITIS
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
ABSCESS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
SKIN BACTERIAL INFECTION
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
General disorders
TREATMENT FAILURE
|
1.3%
2/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Investigations
BLOOD CULTURE POSITIVE
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.64%
1/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.00%
0/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
0.65%
1/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
Other adverse events
| Measure |
Usual Care
n=156 participants at risk
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
|
New Critical Pathway
n=153 participants at risk
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
5.2%
8/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
|
Infections and infestations
Cellulitis
|
1.3%
2/156 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
5.2%
8/153 • Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER