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Status:

TERMINATED

Comparing Oral Versus Parenteral Antimicrobial Therapy

Lead Sponsor:

West Virginia University

Conditions:

Endovascular Infection

Bone and Joint Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimi...

Eligibility Criteria

Inclusion

  • Inclusion (must meet all of the following):
  • English speaking
  • The patient is hospitalized at J.W. Ruby Memorial Hospital, United Hospital Center, Berkeley Medical Center, Wheeling Hospital, or Camden Clark Medical Center
  • The patient has been diagnosed with ≥ 1 of the following: endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, or genitourinary infection
  • The patient is being transitioned to 2-8 weeks of IV antibacterial therapy on hospital discharge
  • The patient has capacity to participate in routine OPAT/COpAT follow-up (telephone check-ins, laboratory monitoring, and in-person or telemedicine ID Clinic follow-up)
  • Exclusion (may not meet any of the following):
  • The patient is not appropriate for OPAT (active injection drug use, lack of infusion resources, and/or unstable outpatient environment)
  • The patient is not appropriate for COpAT (unable to receive PO medication or lack of an effective PO antimicrobial option based on susceptibility testing)
  • The patient is unable to give informed consent
  • The patient is a prisoner, pregnant, and/or mentally handicapped
  • The patient is determined unsafe for enrollment at the primary team's discretion

Exclusion

    Key Trial Info

    Start Date :

    August 4 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 14 2025

    Estimated Enrollment :

    94 Patients enrolled

    Trial Details

    Trial ID

    NCT05977868

    Start Date

    August 4 2023

    End Date

    February 14 2025

    Last Update

    August 26 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    West Virginia University

    Morgantown, West Virginia, United States, 26506