Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NCT ID: NCT02961764
Last Updated: 2020-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
313 participants
INTERVENTIONAL
2016-11-29
2019-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual Care
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Usual Care
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
New Critical Pathway
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
Dalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Interventions
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Usual Care
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Dalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known or suspected gram-positive infection.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Gillard
Role: STUDY_DIRECTOR
Allergan
Locations
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Maricopa Medical Center
Phoenix, Arizona, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Massachusetts
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Wayne State University
Detroit, Michigan, United States
ProMedica Monroe Regional Hospital
Monroe, Michigan, United States
Truman Medical Centers
Kansas City, Missouri, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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More Information
Other Identifiers
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CMO-US-ID-0476
Identifier Type: -
Identifier Source: org_study_id
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