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

Study Identifier
CMO-US-ID-0476
CT.gov Identifier
NCT02961764
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Bacterial Infection
    • Study Drug
  • Usual Care
  • Dalbavancin
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Maricopa Medical Center
    Phoenix, Arizona, United States, 85008
    Status
    Not applicable
    Location
    Olive View-UCLA Medical Center
    Sylmar, California, United States, 91342
    Status
    Not applicable
    Location
    Hartford Hospital
    Hartford, Connecticut, United States, 06102
    Status
    Not applicable
    Location
    Tampa General Hospital
    Tampa, Florida, United States, 33606
    Status
    Not applicable
    Location
    Rush University Medical Center
    Chicago, Illinois, United States, 60612
    Status
    Not applicable
    Location
    Johns Hopkins Hospital
    Baltimore, Maryland, United States, 21287
    Status
    Not applicable
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