Trial Outcomes & Findings for Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (NCT NCT03233438)

NCT ID: NCT03233438

Last Updated: 2020-01-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 91 participants
• Primary outcome timeframe: 44 Days
• Results posted on: 2020-01-18

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	48	43
Overall Study COMPLETED	42	32
Overall Study NOT COMPLETED	6	11

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 Lost to Follow-up	4	9
Overall Study Withdrawal by Subject	2	1
Overall Study No recording of dalbavancin	0	1

Baseline Characteristics

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Baseline characteristics by cohort

Measure	Usual Care n=48 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=42 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=90 Participants Total of all reporting groups
Age, Customized 70-79 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized 80-89 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Customized <20 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 20-29 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Customized 30-39 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Customized 40-49 years	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Age, Customized 50-59 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Customized 60-69 years	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Age, Customized 90-98 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	26 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Patient chose not to answer	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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	4.8 Days Standard Deviation 2.55	3.2 Days Standard Deviation 2.48

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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	4.9 Days Standard Deviation 2.62	3.2 Days Standard Deviation 2.48

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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	48 Participants	41 Participants
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time Expected Surgeries	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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 1 Occurrence	48 Participants	39 Participants
Number of Participants With Infection-related Hospitalizations 2 Occurrences	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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 That Resulted in Admission to Intensive Care Unit Admission to ICU	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Follow-up: 30 Days

Population: 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=48 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=42 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 None	47 Participants	39 Participants
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital 1 Occurrence	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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 None	46 Participants	40 Participants
Number of Participants With Infection-related Emergency Department (ED) Visits 1 Occurrence	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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 None	26 Participants	20 Participants
Number of Participants With Infection-related Outpatient Healthcare Visits Any	22 Participants	22 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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 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	0 Participants
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy Peripheral IV	27 Participants	42 Participants
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy No Line	20 Participants	0 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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 None	45 Participants	41 Participants
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy 1 Occurrence	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: 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.

Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever

Outcome measures

Measure	Usual Care n=48 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=42 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.
Change From Baseline in Response to Treatment at End of Treatment Visit Complete response	24 Participants	24 Participants
Change From Baseline in Response to Treatment at End of Treatment Visit Partial response	0 Participants	0 Participants
Change From Baseline in Response to Treatment at End of Treatment Visit Failure	12 Participants	9 Participants
Change From Baseline in Response to Treatment at End of Treatment Visit Unknown	12 Participants	9 Participants

SECONDARY outcome

Timeframe: 44 Days

Population: 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=48 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=42 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)	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and 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=43 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=34 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 Good	9 Participants	7 Participants
Patient Satisfaction With Care: Overall Health Excellent	2 Participants	8 Participants
Patient Satisfaction With Care: Overall Health Very good	16 Participants	10 Participants
Patient Satisfaction With Care: Overall Health Fair	10 Participants	8 Participants
Patient Satisfaction With Care: Overall Health Poor	6 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions 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=43 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=34 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	5.1 scores on a scale Standard Deviation 3.34	6.9 scores on a scale Standard Deviation 3.12

SECONDARY outcome

Timeframe: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and 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=43 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=34 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	43 Participants	34 Participants
Patient Satisfaction With Care: Hospitalization No	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions 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=43 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=34 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	7.4 scores on a scale Standard Deviation 2.35	7.4 scores on a scale Standard Deviation 2.72

SECONDARY outcome

Timeframe: 14 Days

Population: 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all questions in the usual care group \& new critical pathway group; 42 \& 34 patients answered this question in the usual care group \& 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=42 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=34 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	13 Participants	6 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Stay got in way of daily normal activities	17 Participants	8 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Stay got in the way of providing care to others	10 Participants	5 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Hospital stay was expensive	7 Participants	4 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Did not provide adequate monitoring by providers	4 Participants	4 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Did not provide well trained healthcare providers	3 Participants	1 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Hospital stay made me feel worse	4 Participants	1 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Hospital stay made me feel concerned	11 Participants	7 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Hospital stay was uncomfortable	12 Participants	7 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Hospital stay disrupted my sleep	24 Participants	10 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay Other	5 Participants	6 Participants
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay I was not dissatisfied with my hospital stay	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 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=43 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=34 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	43 Participants	33 Participants
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections No	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey 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=43 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=33 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	7.1 scores on a scale Standard Deviation 2.83	8.1 scores on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: 14 Days

Population: 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this question in the usual care group \& 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=43 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=33 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 Allowed me to return to work/school	14 Participants	15 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Allowed me to return to daily normal activities	15 Participants	20 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Allowed me to return to providing care to others	8 Participants	11 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV IV antibiotic therapy was affordable	6 Participants	4 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Administered at appointments that I could schedule	2 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Administered quickly once arrived at appt	2 Participants	3 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Administered at setting that had convenient hours	3 Participants	7 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Ensured regular monitoring by healthcare providers	22 Participants	10 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Administered by skilled healthcare providers	24 Participants	18 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV IV antibiotic therapy made me feel better	19 Participants	16 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Allowed to receive care for skin infection at home	7 Participants	9 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Convenient to administer by self/caregiver at home	4 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Other	3 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV Not satisfied with receiving IV antibiotic therapy	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this question in the usual care group \& 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=43 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=33 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	11 Participants	3 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Got in way of performing daily normal activities	11 Participants	3 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Got in the way of providing care to others	5 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV IV antibiotic therapy was expensive	2 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Required me to make appointments	0 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Administered at healthcare setting w/limited hours	0 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Required traveling to and from appointments	0 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Required to wait to be seen by provider	0 Participants	5 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV IV antibiotic therapy took too long to administer	4 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Administered too frequently	4 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Required having a PICC or central line inserted	7 Participants	2 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Caused an IV site infection	1 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV IV antibiotic therapy made me feel worse	10 Participants	3 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Not adequately monitored by healthcare providers	3 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Not administered by skilled healthcare providers	0 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV IV antibiotic therapy made me feel concerned	7 Participants	3 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Required a nurse/healthcare worker coming to home	0 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Required administration to self/caregiver at home	0 Participants	1 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Other	1 Participants	0 Participants
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV Not dissatisfied w/receiving IV antibiotic therapy	19 Participants	22 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 42 \& 33 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=42 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=33 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	17 Participants	26 Participants
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living A little of the time	4 Participants	5 Participants
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living Some of the time	3 Participants	0 Participants
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living Most of the time	6 Participants	1 Participants
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living All of the time	12 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 42 \& 33 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=42 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=33 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	23 Participants	26 Participants
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy A little of the time	13 Participants	4 Participants
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy Some of the time	3 Participants	1 Participants
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy Most of the time	1 Participants	1 Participants
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy All of the time	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey 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=43 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=33 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	7.3 scores on a scale Standard Deviation 2.63	8.7 scores on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey 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=43 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=33 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	7.5 scores on a scale Standard Deviation 2.58	8.9 scores on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 34 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=43 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=34 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	28 Participants	33 Participants
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV Regimen 2	6 Participants	0 Participants
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV Regimen 3	9 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 41 \& 34 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=41 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=34 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	23 Participants	22 Participants
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV About 1 hour	10 Participants	10 Participants
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV About 1.5 to 2 hours	5 Participants	1 Participants
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV About 3 hours or longer	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 34 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=43 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=34 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 so	34 Participants	30 Participants
Patient Satisfaction With Care: Find Value in a Physician Definitely not	1 Participants	1 Participants
Patient Satisfaction With Care: Find Value in a Physician Probably not	1 Participants	1 Participants
Patient Satisfaction With Care: Find Value in a Physician Probably so	7 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 10-14

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively.14 and 9 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 17 and 20 patients were employed.

Outcome measures

Measure	Usual Care n=43 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=34 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	49.9 Percentage Standard Deviation 38.49	36.7 Percentage Standard Deviation 46.09
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire Impairment while working	47.9 Percentage Standard Deviation 40.03	8.9 Percentage Standard Deviation 9.28
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire Overall work impairment	59.3 Percentage Standard Deviation 39.16	18.0 Percentage Standard Deviation 23.39
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire Activity impairment	60.2 Percentage Standard Deviation 38.85	18.5 Percentage Standard Deviation 26.23

SECONDARY outcome

Timeframe: Day 14

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 42 and 34 patients completed all survey questions in the usual care group and 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=42 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=34 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	43.9 score on a scale Standard Deviation 10.28	50.8 score on a scale Standard Deviation 10.85
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire Physical Health Component Score	40.5 score on a scale Standard Deviation 11.37	46.3 score on a scale Standard Deviation 11.15

SECONDARY outcome

Timeframe: 44 Days

Population: 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.

Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests

Outcome measures

Measure	Usual Care n=48 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=42 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.
Healthcare Costs	13772.9 USD Standard Deviation 7166.95	9421.6 USD Standard Deviation 7122.57

Adverse Events

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

New Critical Pathway

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=48 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=42 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.
Metabolism and nutrition disorders Hypoglycaemia	2.1% 1/48 • 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% 0/42 • 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	0.00% 0/48 • 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.	4.8% 2/42 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/48 • 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.	2.4% 1/42 • 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=48 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=42 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.
General disorders Pyrexia	0.00% 0/48 • 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.	7.1% 3/42 • 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

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: IR-CTRegistration@allergan.com

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