Development 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: NCT03233438
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.2
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections
• Actual Study Start Date: Jul 24, 2017
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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®
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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

4. Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit [44 Days]

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

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

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

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

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

10. Change From Baseline in Response to Treatment at End of Treatment Visit [Baseline, Day 14]

    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

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

12. Patient Satisfaction With Care: Overall Health [14 Days]

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

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

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

14. Patient Satisfaction With Care: Hospitalization [14 Days]

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

15. Patient Satisfaction With Care: Satisfaction With Hospital Stay [14 Days]

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

16. Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay [14 Days]

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

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

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

18. Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy [14 Days]

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

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

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

20. 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).

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

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

22. Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy [14 Days]

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

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

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

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

    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: Regimen Preferred if Treated Again for a Similar Skin Infection With IV [14 Days]

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

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

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

27. Patient Satisfaction With Care: Find Value in a Physician [14 Days]

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

28. Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire [Day 10-14]

29. 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.

30. Healthcare Costs [44 Days]

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Admitted patients who 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	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Patrick Gillard, Allergan

Study Documents (Full-Text)

• Study Protocol - Mar 3, 2017
• Statistical Analysis Plan - May 9, 2018

More Information

Additional Information:

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [e-mail] for assistance.

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03233438
• Other Study ID Numbers: CMO-US-ID-0528
• First Posted: Jul 28, 2017
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 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; Bacterial Infections; 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	48	43
COMPLETED	42	32
NOT COMPLETED	6	11

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	48	42	90
Age, Customized (Count of Participants)
<20 years	0 0%	0 0%	0 0%
20-29 years	6 12.5%	5 11.9%	11 12.2%
30-39 years	6 12.5%	8 19%	14 15.6%
40-49 years	4 8.3%	8 19%	12 13.3%
50-59 years	7 14.6%	5 11.9%	12 13.3%
60-69 years	10 20.8%	5 11.9%	15 16.7%
70-79 years	4 8.3%	3 7.1%	7 7.8%
80-89 years	7 14.6%	7 16.7%	14 15.6%
90-98 years	4 8.3%	1 2.4%	5 5.6%
Sex: Female, Male (Count of Participants)
Female	24 50%	20 47.6%	44 48.9%
Male	24 50%	22 52.4%	46 51.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 14.6%	8 19%	15 16.7%
Not Hispanic or Latino	38 79.2%	26 61.9%	64 71.1%
Unknown or Not Reported	3 6.3%	8 19%	11 12.2%
Race/Ethnicity, Customized (Count of Participants)
White or Caucasian	36 75%	28 66.7%	64 71.1%
Black or African American	1 2.1%	7 16.7%	8 8.9%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.1%	1 2.4%	2 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	1 2.4%	1 1.1%
Other	0 0%	0 0%	0 0%
Patient chose not to answer	10 20.8%	5 11.9%	15 16.7%

Outcome Measures

1. Primary 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.

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	48	42
Mean (Standard Deviation) [Days]	4.8 (2.55)	3.2 (2.48)

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	0.003
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; 0.6 to 2.6
	Parameter Dispersion	Type: Standard Deviation; Value: 2.5
	Estimation Comments

2. Secondary Outcome

Title	Number of 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.

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	48	42
Mean (Standard Deviation) [Days]	4.9 (2.62)	3.2 (2.48)

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	0.003
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.6 to 2.8
	Parameter Dispersion	Type: Standard Deviation; Value: 2.56
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Infection-related Major Surgical Interventions 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.

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	48	42
No Surgeries	48 100%	41 97.6%
Expected Surgeries	0 0%	1 2.4%

4. Secondary Outcome

Title	Number of Participants With 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.

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	48	42
1 Occurrence	48 100%	39 92.9%
2 Occurrences	0 0%	3 7.1%

5. Secondary Outcome

Title	Number of Participants With Infection-related Hospitalizations 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.

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	48	42
Admission to ICU	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
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.

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	48	42
None	47 97.9%	39 92.9%
1 Occurrence	1 2.1%	3 7.1%

7. 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.

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	48	42
None	46 95.8%	40 95.2%
1 Occurrence	2 4.2%	2 4.8%

8. 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.

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	48	42
None	26 54.2%	20 47.6%
Any	22 45.8%	22 52.4%

9. 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.

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	48	42
Central Line	0 0%	0 0%
PICC Line	1 2.1%	0 0%
Peripheral IV	27 56.3%	42 100%
No Line	20 41.7%	0 0%

10. 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.

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	48	42
None	45 93.8%	41 97.6%
1 Occurrence	3 6.3%	1 2.4%

11. Secondary Outcome

Title	Change From Baseline in Response to Treatment at End of Treatment Visit
Description	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
Time Frame	Baseline, Day 14

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	48	42
Complete response	24 50%	24 57.1%
Partial response	0 0%	0 0%
Failure	12 25%	9 21.4%
Unknown	12 25%	9 21.4%

12. 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	48	42
Count of Participants [Participants]	1 2.1%	3 7.1%

13. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Excellent	2 4.2%	8 19%
Very good	16 33.3%	10 23.8%
Good	9 18.8%	7 16.7%
Fair	10 20.8%	8 19%
Poor	6 12.5%	1 2.4%

14. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Mean (Standard Deviation) [scores on a scale]	5.1 (3.34)	6.9 (3.12)

15. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Yes	43 89.6%	34 81%
No	0 0%	0 0%

16. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Mean (Standard Deviation) [scores on a scale]	7.4 (2.35)	7.4 (2.72)

17. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	42	34
Hospital stay interfered with work/school	13 27.1%	6 14.3%
Stay got in way of daily normal activities	17 35.4%	8 19%
Stay got in the way of providing care to others	10 20.8%	5 11.9%
Hospital stay was expensive	7 14.6%	4 9.5%
Did not provide adequate monitoring by providers	4 8.3%	4 9.5%
Did not provide well trained healthcare providers	3 6.3%	1 2.4%
Hospital stay made me feel worse	4 8.3%	1 2.4%
Hospital stay made me feel concerned	11 22.9%	7 16.7%
Hospital stay was uncomfortable	12 25%	7 16.7%
Hospital stay disrupted my sleep	24 50%	10 23.8%
Other	5 10.4%	6 14.3%
I was not dissatisfied with my hospital stay	12 25%	12 28.6%

18. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Yes	43 89.6%	33 78.6%
No	0 0%	1 2.4%

19. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	33
Mean (Standard Deviation) [scores on a scale]	7.1 (2.83)	8.1 (2.26)

20. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	33
Allowed me to return to work/school	14 29.2%	15 35.7%
Allowed me to return to daily normal activities	15 31.3%	20 47.6%
Allowed me to return to providing care to others	8 16.7%	11 26.2%
IV antibiotic therapy was affordable	6 12.5%	4 9.5%
Administered at appointments that I could schedule	2 4.2%	1 2.4%
Administered quickly once arrived at appt	2 4.2%	3 7.1%
Administered at setting that had convenient hours	3 6.3%	7 16.7%
Ensured regular monitoring by healthcare providers	22 45.8%	10 23.8%
Administered by skilled healthcare providers	24 50%	18 42.9%
IV antibiotic therapy made me feel better	19 39.6%	16 38.1%
Allowed to receive care for skin infection at home	7 14.6%	9 21.4%
Convenient to administer by self/caregiver at home	4 8.3%	0 0%
Other	3 6.3%	1 2.4%
Not satisfied with receiving IV antibiotic therapy	3 6.3%	2 4.8%

21. 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

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.

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	43	33
Got in the way of work/school	11 22.9%	3 7.1%
Got in way of performing daily normal activities	11 22.9%	3 7.1%
Got in the way of providing care to others	5 10.4%	1 2.4%
IV antibiotic therapy was expensive	2 4.2%	0 0%
Required me to make appointments	0 0%	0 0%
Administered at healthcare setting w/limited hours	0 0%	0 0%
Required traveling to and from appointments	0 0%	1 2.4%
Required to wait to be seen by provider	0 0%	5 11.9%
IV antibiotic therapy took too long to administer	4 8.3%	1 2.4%
Administered too frequently	4 8.3%	1 2.4%
Required having a PICC or central line inserted	7 14.6%	2 4.8%
Caused an IV site infection	1 2.1%	0 0%
IV antibiotic therapy made me feel worse	10 20.8%	3 7.1%
Not adequately monitored by healthcare providers	3 6.3%	0 0%
Not administered by skilled healthcare providers	0 0%	0 0%
IV antibiotic therapy made me feel concerned	7 14.6%	3 7.1%
Required a nurse/healthcare worker coming to home	0 0%	1 2.4%
Required administration to self/caregiver at home	0 0%	1 2.4%
Other	1 2.1%	0 0%
Not dissatisfied w/receiving IV antibiotic therapy	19 39.6%	22 52.4%

22. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	42	33
None of the time	17 35.4%	26 61.9%
A little of the time	4 8.3%	5 11.9%
Some of the time	3 6.3%	0 0%
Most of the time	6 12.5%	1 2.4%
All of the time	12 25%	1 2.4%

23. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	42	33
None of the time	23 47.9%	26 61.9%
A little of the time	13 27.1%	4 9.5%
Some of the time	3 6.3%	1 2.4%
Most of the time	1 2.1%	1 2.4%
All of the time	2 4.2%	1 2.4%

24. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	33
Mean (Standard Deviation) [scores on a scale]	7.3 (2.63)	8.7 (1.89)

25. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	33
Mean (Standard Deviation) [scores on a scale]	7.5 (2.58)	8.9 (1.9)

26. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Regimen 1	28 58.3%	33 78.6%
Regimen 2	6 12.5%	0 0%
Regimen 3	9 18.8%	1 2.4%

27. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	41	34
About 30 minutes or less	23 47.9%	22 52.4%
About 1 hour	10 20.8%	10 23.8%
About 1.5 to 2 hours	5 10.4%	1 2.4%
About 3 hours or longer	3 6.3%	1 2.4%

28. 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	14 Days

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Definitely not	1 2.1%	1 2.4%
Probably not	1 2.1%	1 2.4%
Probably so	7 14.6%	2 4.8%
Definitely so	34 70.8%	30 71.4%

29. Secondary Outcome

Title	Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Time Frame	Day 10-14

Outcome Measure Data

Analysis Population Description

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.

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	43	34
Absenteeism	49.9 (38.49)	36.7 (46.09)
Impairment while working	47.9 (40.03)	8.9 (9.28)
Overall work impairment	59.3 (39.16)	18.0 (23.39)
Activity impairment	60.2 (38.85)	18.5 (26.23)

30. 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. 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.

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	42	34
Mental Health Component Score	43.9 (10.28)	50.8 (10.85)
Physical Health Component Score	40.5 (11.37)	46.3 (11.15)

31. Secondary Outcome

Title	Healthcare Costs
Description	Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
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	48	42
Mean (Standard Deviation) [USD]	13772.9 (7166.95)	9421.6 (7122.57)

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	0/48 (0%)		0/42 (0%)
Serious Adverse Events
	Usual Care		New Critical Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/48 (2.1%)		3/42 (7.1%)
Gastrointestinal disorders
Vomiting	0/48 (0%)		1/42 (2.4%)
Infections and infestations
Cellulitis	0/48 (0%)		2/42 (4.8%)
Metabolism and nutrition disorders
Hypoglycaemia	1/48 (2.1%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		New Critical Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		3/42 (7.1%)
General disorders
Pyrexia	0/48 (0%)		3/42 (7.1%)

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.