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

Study Identifier
CMO-US-ID-0528
CT.gov Identifier
NCT03233438
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
  • Dalbavancin
  • Usual Care
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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)

    Study Locations

    Location
    Status
    Location
    Weill Cornell Medicine
    New York, New York, United States, 10065
    Status
    Not applicable