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

Primary Purpose

Acute Bacterial Skin and Skin Structure Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Dalbavancin
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Skin and Skin Structure Infections focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maricopa Medical Center
  • Olive View-UCLA Medical Center
  • Hartford Hospital
  • Tampa General Hospital
  • Rush University Medical Center
  • Johns Hopkins Hospital
  • University of Massachusetts
  • Henry Ford Hospital
  • Wayne State University
  • ProMedica Monroe Regional Hospital
  • Truman Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual Care

New Critical Pathway

Arm 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.

Outcomes

Primary Outcome Measures

Hospital Admission Rate at Initial Episode of Care

Secondary Outcome Measures

Number of Total Admitted Hospital Days
Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Number of all major surgical interventions unexpected or expected that required operating room time
Number of Infection-related Total Admitted Hospital Days
Number of Participants With Infection-related Hospitalizations
Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations
Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
Number of Participants With Infection-related Emergency Department (ED) Visits
Number of Participants With Infection-related Outpatient Healthcare Visits
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Number of Participants With Serious Adverse Events (SAEs)
Patient Satisfaction With Care: Overall Health
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Wait in Emergency Room
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Find Value in a Physician
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
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.

Full Information

First Posted
November 7, 2016
Last Updated
March 27, 2020
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02961764
Brief Title
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Official Title
A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin Structure Infections
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Arm Title
New Critical Pathway
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Usual Care
Intervention Description
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Intervention Type
Drug
Intervention Name(s)
Dalbavancin
Other Intervention Name(s)
Dalvance®
Intervention Description
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Primary Outcome Measure Information:
Title
Hospital Admission Rate at Initial Episode of Care
Time Frame
44 Days
Secondary Outcome Measure Information:
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
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
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
Title
Number of Infection-related Total Admitted Hospital Days
Time Frame
44 Days
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
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
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
Title
Number of Participants With Infection-related Emergency Department (ED) Visits
Time Frame
44 Days
Title
Number of Participants With Infection-related Outpatient Healthcare Visits
Time Frame
44 Days
Title
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Time Frame
44 Days
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
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
44 Days
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Gillard
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
ProMedica Monroe Regional Hospital
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Facility Name
Truman Medical Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33780567
Citation
Talan DA, Mower WR, Lovecchio FA, Rothman RE, Steele MT, Keyloun K, Gillard P, Copp R, Moran GJ. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections. Acad Emerg Med. 2021 Oct;28(10):1108-1117. doi: 10.1111/acem.14258. Epub 2021 May 5.
Results Reference
derived
Links:
URL
http://allerganclinicaltrials.com
Description
More Information

Learn more about this trial

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

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