Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
1 other identifier
interventional
313
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2016
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedStudy Start
First participant enrolled
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedResults Posted
Study results publicly available
April 10, 2020
CompletedApril 10, 2020
March 1, 2020
2.3 years
November 7, 2016
March 27, 2020
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Admission Rate at Initial Episode of Care
44 Days
Secondary Outcomes (34)
Number of Total Admitted Hospital Days
44 Days
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
Initial Care: 14 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
44 Days
Number of Infection-related Total Admitted Hospital Days
44 Days
Number of Participants With Infection-related Hospitalizations
44 Days
- +29 more secondary outcomes
Study Arms (2)
Usual Care
ACTIVE COMPARATORParticipants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
New Critical Pathway
ACTIVE COMPARATORThe 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.
Interventions
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (11)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Olive View-UCLA Medical Center
Sylmar, California, 91342, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Wayne State University
Detroit, Michigan, 48202, United States
ProMedica Monroe Regional Hospital
Monroe, Michigan, 48162, United States
Truman Medical Centers
Kansas City, Missouri, 64108, United States
Related Publications (1)
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.
PMID: 33780567DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Patrick Gillard
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 11, 2016
Study Start
November 29, 2016
Primary Completion
March 29, 2019
Study Completion
March 29, 2019
Last Updated
April 10, 2020
Results First Posted
April 10, 2020
Record last verified: 2020-03