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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02961764
• Collaborator: (none)
• Enrollment: 313
• Locations: 11
• Arms: 2
• Actual Duration (Months): 27.9
• Patients Per Site: 28.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.

Condition or Disease	Intervention/Treatment	Phase
Acute Bacterial Skin and Skin Structure Infections	Drug: Usual Care; Drug: Dalbavancin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 313 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
• Actual Study Start Date: Nov 29, 2016
• Actual Primary Completion Date: Mar 29, 2019
• Actual Study Completion Date: Mar 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	Drug: Usual Care; Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Active Comparator: 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.	Drug: Dalbavancin; Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.; Other Names: Dalvance®

Outcome Measures

Primary Outcome Measures

1. Hospital Admission Rate at Initial Episode of Care [44 Days]

Secondary Outcome Measures

1. Number of Total Admitted Hospital Days [44 Days]

   Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations

2. Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care [Initial Care: 14 Days]

   Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)

3. Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time [44 Days]

   Number of all major surgical interventions unexpected or expected that required operating room time

4. Number of Infection-related Total Admitted Hospital Days [44 Days]

5. Number of Participants With Infection-related Hospitalizations [44 Days]

   Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations

6. Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit [44 Days]

7. Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED [Follow-up: 30 Days]

8. Number of Participants With Infection-related Emergency Department (ED) Visits [44 Days]

9. Number of Participants With Infection-related Outpatient Healthcare Visits [44 Days]

10. Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy [44 Days]

11. Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy [44 Days]

12. Number of Participants With Serious Adverse Events (SAEs) [44 Days]

13. Patient Satisfaction With Care: Overall Health [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

14. Patient Satisfaction With Care: Wait in Emergency Room [Day 14]

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

15. Patient Satisfaction With Care: Hospitalization [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

16. Patient Satisfaction With Care: Satisfaction With Hospital Stay [Day 14]

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

17. Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

18. Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

19. Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy [Day 14]

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

20. Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

21. Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV [14 Days]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

22. Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

23. Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

24. Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day [Day 14]

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

25. Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV [Day 14]

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

26. Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV [14 days]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

27. Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider [14 days]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

28. Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV [14 Days]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

29. Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care [14 Days]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

30. Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

31. Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

32. Patient Satisfaction With Care: Find Value in a Physician [Day 14]

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

33. Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire [Day 14]

    Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire

34. Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire [Day 14]

    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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Presents to the Emergency Department (ED) and meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

• Known or suspected gram-positive infection.

Exclusion Criteria:

• Known or suspected gram-negative infections, anaerobic infections, or fungemia

• Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance

• Injection drug users with a fever

• Severe neurological disorder leading to immobility or confined to a wheelchair

• Bilateral Lower extremity involvement of the suspected infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Medical Center	Phoenix	Arizona	United States	85008
2	Olive View-UCLA Medical Center	Sylmar	California	United States	91342
3	Hartford Hospital	Hartford	Connecticut	United States	06102
4	Tampa General Hospital	Tampa	Florida	United States	33606
5	Rush University Medical Center	Chicago	Illinois	United States	60612
6	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
7	University of Massachusetts	Worcester	Massachusetts	United States	01655
8	Henry Ford Hospital	Detroit	Michigan	United States	48202
9	Wayne State University	Detroit	Michigan	United States	48202
10	ProMedica Monroe Regional Hospital	Monroe	Michigan	United States	48162
11	Truman Medical Centers	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Patrick Gillard, Allergan

Study Documents (Full-Text)

• Study Protocol - Jan 11, 2018
• Statistical Analysis Plan - Feb 5, 2019

More Information

Additional Information:

• More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02961764
• Other Study ID Numbers: CMO-US-ID-0476
• First Posted: Nov 11, 2016
• Last Update Posted: Apr 10, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allergan: Critical Pathways; Health Facilities; Clinical Protocols; Patient Satisfaction; Absenteeism; Anti-Bacterial Agents; Quality of Life; Economics, Medical; Health Resources; Health resource utilization; Acute bacterial skin and skin structure infection (ABSSSI)
• Additional relevant MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial; Dalbavancin

Study Results

Participant Flow

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Period Title: Overall Study
STARTED	160	153
COMPLETED	121	128
NOT COMPLETED	39	25

Baseline Characteristics

Arm/Group Title	Usual Care	New Critical Pathway	Total
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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 of all reporting groups
Overall Participants	156	153	309
Age, Customized (Count of Participants)
<20 years	1 0.6%	2 1.3%	3 1%
20-29 years	28 17.9%	14 9.2%	42 13.6%
30-39 years	31 19.9%	40 26.1%	71 23%
40-49 years	25 16%	29 19%	54 17.5%
50-59 years	37 23.7%	31 20.3%	68 22%
60-69 years	22 14.1%	24 15.7%	46 14.9%
70-79 years	8 5.1%	9 5.9%	17 5.5%
80-89 years	3 1.9%	3 2%	6 1.9%
90-98 years	1 0.6%	1 0.7%	2 0.6%
Sex: Female, Male (Count of Participants)
Female	56 35.9%	54 35.3%	110 35.6%
Male	100 64.1%	99 64.7%	199 64.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	39 25%	43 28.1%	82 26.5%
Not Hispanic or Latino	116 74.4%	107 69.9%	223 72.2%
Unknown or Not Reported	1 0.6%	3 2%	4 1.3%
Race/Ethnicity, Customized (Count of Participants)
White or Caucasian	89 57.1%	91 59.5%	180 58.3%
Black or African American	30 19.2%	39 25.5%	69 22.3%
American Indian or Alaska Native	6 3.8%	2 1.3%	8 2.6%
Asian	1 0.6%	2 1.3%	3 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Other	17 10.9%	16 10.5%	33 10.7%
Patient chose not to answer	13 8.3%	3 2%	16 5.2%

Outcome Measures

1. Primary Outcome

Title	Hospital Admission Rate at Initial Episode of Care
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	156	153
Yes	60 38.5%	27 17.6%
No	96 61.5%	126 82.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, New Critical Pathway
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.289
	Confidence Interval	(2-Sided) 95%; 0.156 to 0.532
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Total Admitted Hospital Days
Description	Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Mean (Standard Deviation) [Days]	2.3 (3.74)	1.2 (2.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, New Critical Pathway
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	t-test, 1 sided
	Comments

3. Secondary Outcome

Title	Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
Description	Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
Time Frame	Initial Care: 14 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	156	153
Mean (Standard Deviation) [Hours]	7.7 (9.09)	6.1 (3.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, New Critical Pathway
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.050
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Description	Number of all major surgical interventions unexpected or expected that required operating room time
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
No Surgeries	107 68.6%	106 69.3%
Any Surgeries	38 24.4%	35 22.9%

5. Secondary Outcome

Title	Number of Infection-related Total Admitted Hospital Days
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Mean (Standard Deviation) [Days]	2.0 (3.06)	1.0 (2.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, New Critical Pathway
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	t-test, 1 sided
	Comments

6. Secondary Outcome

Title	Number of Participants With Infection-related Hospitalizations
Description	Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
None	85 54.5%	110 71.9%
Any	60 38.5%	31 20.3%

7. Secondary Outcome

Title	Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Admission to ICU	3 1.9%	0 0%

8. Secondary Outcome

Title	Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
Time Frame	Follow-up: 30 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Number [Participants]	7 4.5%	12 7.8%

9. Secondary Outcome

Title	Number of Participants With Infection-related Emergency Department (ED) Visits
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Number [Participants]	22 14.1%	19 12.4%

10. Secondary Outcome

Title	Number of Participants With Infection-related Outpatient Healthcare Visits
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Number [Participants]	57 36.5%	39 25.5%

11. Secondary Outcome

Title	Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
Peripheral IV	93 59.6%	141 92.2%
Central line	0 0%	0 0%
PICC line	1 0.6%	1 0.7%
No Line	143 91.7%	136 88.9%

12. Secondary Outcome

Title	Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	145	141
1 occurence	2 1.3%	1 0.7%

13. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Time Frame	44 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	156	153
Count of Participants [Participants]	11 7.1%	16 10.5%

14. Secondary Outcome

Title	Patient Satisfaction With Care: Overall Health
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Excellent	12 7.7%	22 14.4%
Very good	38 24.4%	31 20.3%
Good	35 22.4%	40 26.1%
Fair	30 19.2%	23 15%
Poor	4 2.6%	8 5.2%

15. Secondary Outcome

Title	Patient Satisfaction With Care: Wait in Emergency Room
Description	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Mean (Standard Deviation) [scores on a scale]	7.8 (2.63)	8.3 (2.25)

16. Secondary Outcome

Title	Patient Satisfaction With Care: Hospitalization
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Yes	63 40.4%	27 17.6%
No	56 35.9%	97 63.4%

17. Secondary Outcome

Title	Patient Satisfaction With Care: Satisfaction With Hospital Stay
Description	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	63	27
Mean (Standard Deviation) [Scores on a Scale]	8.2 (2.19)	8.0 (1.85)

18. Secondary Outcome

Title	Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Hospital stay interfered with work/school	11	8
Stay got in way of daily normal activities	11	10
Stay got in the way of providing care to others	8	8
Hospital stay was expensive	2	6
Did not provide adequate monitoring by providers	3	1
Did not provide well trained healthcare providers	3	0
Hospital stay made me feel worse	3	0
Hospital stay made me feel concerned	14	7
Hospital stay was uncomfortable	11	5
Hospital stay disrupted my sleep	12	6
Other	7	2
I was not dissatisfied with my hospital stay	33	12

19. Secondary Outcome

Title	Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Yes	87 55.8%	119 77.8%
No	32 20.5%	5 3.3%

20. Secondary Outcome

Title	Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Description	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	86	119
Mean (Standard Deviation) [Scores on a Scale]	8.7 (2.16)	9.0 (1.63)

21. Secondary Outcome

Title	Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Allowed me to return to work/school	37 23.7%	50 32.7%
Allowed me to return to daily normal activities	48 30.8%	81 52.9%
Allowed me to return to providing care to others	38 24.4%	52 34%
IV antibiotic therapy was affordable	29 18.6%	45 29.4%
Administered at appointments that I could schedule	4 2.6%	11 7.2%
Administered quickly once arrived at appt	4 2.6%	17 11.1%
Administered at setting that had convenient hours	3 1.9%	16 10.5%
Ensured regular monitoring by healthcare providers	26 16.7%	29 19%
Administered by skilled healthcare providers	51 32.7%	58 37.9%
IV antibiotic therapy made me feel better	55 35.3%	80 52.3%
Allowed to receive care for skin infection at home	4 2.6%	10 6.5%
Convenient to administer by self/caregiver at home	2 1.3%	4 2.6%
Other	4 2.6%	8 5.2%
Not satisfied with receiving IV antibiotic therapy	9 5.8%	3 2%

22. Secondary Outcome

Title	Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	14 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
Got in the way of work/school	2 1.3%	1 0.7%
Got in way of performing daily normal activities	3 1.9%	4 2.6%
Got in the way of providing care to others	1 0.6%	1 0.7%
IV antibiotic therapy was expensive	0 0%	0 0%
Required me to make appointments	1 0.6%	0 0%
Administered at healthcare setting w/limited hours	1 0.6%	0 0%
Required traveling to and from appointments	0 0%	0 0%
Required to wait to be seen by provider	1 0.6%	2 1.3%
IV antibiotic therapy took too long to administer	1 0.6%	3 2%
Required having a PICC or central line inserted	2 1.3%	2 1.3%
Caused an IV site infection	0 0%	0 0%
IV antibiotic therapy made me feel worse	2 1.3%	2 1.3%
Not adequately monitored by healthcare providers	1 0.6%	0 0%
Not administered by skilled healthcare providers	1 0.6%	0 0%
IV antibiotic therapy made me feel concerned	2 1.3%	2 1.3%
Required a nurse/healthcare worker coming to home	0 0%	0 0%
Required administration to self/caregiver at home	0 0%	0 0%
Other	4 2.6%	1 0.7%
Not dissatisfied w/receiving IV antibiotic therapy	72 46.2%	105 68.6%

23. Secondary Outcome

Title	Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	87	118
None of the time	66 42.3%	94 61.4%
A little of the time	6 3.8%	10 6.5%
Some of the time	6 3.8%	11 7.2%
Most of the time	5 3.2%	1 0.7%
All of the time	4 2.6%	2 1.3%

24. Secondary Outcome

Title	Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	87	118
None of the time	62 39.7%	80 52.3%
A little of the time	8 5.1%	19 12.4%
Some of the time	8 5.1%	12 7.8%
Most of the time	5 3.2%	3 2%
All of the time	4 2.6%	4 2.6%

25. Secondary Outcome

Title	Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
Description	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	85	118
Mean (Standard Deviation) [Scores on a scale]	8.4 (2.36)	9.0 (1.70)

26. Secondary Outcome

Title	Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
Description	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	85	118
Mean (Standard Deviation) [Scores on a Scale]	8.6 (1.87)	8.8 (1.88)

27. Secondary Outcome

Title	Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	86	118
Less than 15 minutes	7 4.5%	19 12.4%
16 - 30 minutes	5 3.2%	17 11.1%
31 - 60 minutes	2 1.3%	4 2.6%
61 - 90 minutes	1 0.6%	1 0.7%
More than 90 minutes	2 1.3%	0 0%
I did not need to travel to my appointments	68 43.6%	77 50.3%
I don't remember	1 0.6%	0 0%

28. Secondary Outcome

Title	Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	86	118
Less than 15 minutes	4 2.6%	17 11.1%
16 - 30 minutes	7 4.5%	10 6.5%
31 - 60 minutes	3 1.9%	4 2.6%
61 - 90 minutes	3 1.9%	2 1.3%
More than 90 minutes	2 1.3%	8 5.2%
I did not need to wait for my appointments	67 42.9%	75 49%
I don't remember	0 0%	2 1.3%

29. Secondary Outcome

Title	Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	14 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	116	123
Overnight hospital stay for one or more nights	42 26.9%	17 11.1%
Outpatient care: Brief hospital visit w/no stay	74 47.4%	106 69.3%

30. Secondary Outcome

Title	Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	14 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	124
To avoid hospital stay for 1 or more nights	52 33.3%	91 59.5%
To allow me to return to work/school	37 23.7%	44 28.8%
To return to performing daily normal living	48 30.8%	65 42.5%
To allow me to return to providing care to others	27 17.3%	36 23.5%
Outpatient care would be more affordable	21 13.5%	38 24.8%
Outpatient care would be more convenient	43 27.6%	64 41.8%
To ensure monitoring by healthcare providers	10 6.4%	22 14.4%
Administered by skilled healthcare providers	17 10.9%	27 17.6%
Other	3 1.9%	1 0.7%
I would not prefer outpatient care	38 24.4%	14 9.2%

31. Secondary Outcome

Title	Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	117	121
Regimen 1	65 41.7%	107 69.9%
Regimen 2	14 9%	6 3.9%
Regimen 3	38 24.4%	8 5.2%

32. Secondary Outcome

Title	Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	117	123
About 30 minutes or less	73 46.8%	87 56.9%
About 1 hour	28 17.9%	32 20.9%
About 1.5 to 2 hours	13 8.3%	3 2%
About 3 hours or longer	3 1.9%	1 0.7%

33. Secondary Outcome

Title	Patient Satisfaction With Care: Find Value in a Physician
Description	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	115	123
Definitely not	13 8.3%	5 3.3%
Probably not	13 8.3%	8 5.2%
Probably so	38 24.4%	37 24.2%
Definitely so	51 32.7%	73 47.7%

34. Secondary Outcome

Title	Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Description	Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	123
Absenteeism	17.4 (31.96)	18.9 (33.49)
Impairment while working	14.5 (24.14)	10.8 (22.30)
Overall work impairment	21.3 (29.04)	16.4 (26.82)
Activity impairment	24.2 (34.06)	15.9 (28.88)

35. Secondary Outcome

Title	Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Description	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.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS population. 119 and 122 patients provided any and all survey data in the usual care group and the new critical pathway group, respectively.

Arm/Group Title	Usual Care	New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	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.
Measure Participants	119	122
Mental Health Component Score	51.2 (10.36)	52.6 (9.63)
Physical Health Component Score	46.4 (10.36)	47.8 (9.39)

Adverse Events

Time Frame	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.
Arm/Group Title	Usual Care		New Critical Pathway
Arm/Group Description	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.		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.
All Cause Mortality
	Usual Care		New Critical Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/156 (1.3%)		2/153 (1.3%)
Serious Adverse Events
	Usual Care		New Critical Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/156 (7.1%)		16/153 (10.5%)
Cardiac disorders
CARDIAC FAILURE CONGESTIVE	1/156 (0.6%)		0/153 (0%)
CORONARY ARTERY DISEASE	1/156 (0.6%)		0/153 (0%)
General disorders
TREATMENT FAILURE	2/156 (1.3%)		0/153 (0%)
Immune system disorders
ANAPHYLACTIC REACTION	1/156 (0.6%)		0/153 (0%)
Infections and infestations
CELLULITIS	2/156 (1.3%)		8/153 (5.2%)
SKIN INFECTION	2/156 (1.3%)		0/153 (0%)
BRONCHITIS	1/156 (0.6%)		0/153 (0%)
ABSCESS	0/156 (0%)		1/153 (0.7%)
BACTERAEMIA	0/156 (0%)		1/153 (0.7%)
CLOSTRIDIUM DIFFICILE COLITIS	0/156 (0%)		1/153 (0.7%)
LYMPHANGITIS	0/156 (0%)		1/153 (0.7%)
SKIN BACTERIAL INFECTION	0/156 (0%)		1/153 (0.7%)
SUBCUTANEOUS ABSCESS	0/156 (0%)		1/153 (0.7%)
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT	1/156 (0.6%)		0/153 (0%)
SOFT TISSUE INJURY	0/156 (0%)		1/153 (0.7%)
Investigations
BLOOD CULTURE POSITIVE	1/156 (0.6%)		0/153 (0%)
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS	0/156 (0%)		1/153 (0.7%)
Nervous system disorders
CEREBRAL HAEMORRHAGE	1/156 (0.6%)		0/153 (0%)
CEREBROVASCULAR ACCIDENT	1/156 (0.6%)		0/153 (0%)
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY	1/156 (0.6%)		0/153 (0%)
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE	1/156 (0.6%)		0/153 (0%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	1/156 (0.6%)		0/153 (0%)
PULMONARY EMBOLISM	0/156 (0%)		1/153 (0.7%)
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT	0/156 (0%)		1/153 (0.7%)
HIDRADENITIS	0/156 (0%)		1/153 (0.7%)
Vascular disorders
DEEP VEIN THROMBOSIS	0/156 (0%)		1/153 (0.7%)
Other (Not Including Serious) Adverse Events
	Usual Care		New Critical Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/156 (2.6%)		16/153 (10.5%)
Gastrointestinal disorders
Diarrhoea	2/156 (1.3%)		8/153 (5.2%)
Infections and infestations
Cellulitis	2/156 (1.3%)		8/153 (5.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.