Comparing Oral Versus Parenteral Antimicrobial Therapy
Status:
Enrolling by invitation
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
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) antimicrobial therapy to complex outpatient oral antimicrobial therapy
(COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft
tissue, pulmonary, gastrointestinal, and genitourinary infections).
All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be
evaluated by the research team with respect to inclusion/exclusion criteria. If determined
eligible for enrollment, patients will be approached by a study investigator who will present
the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using
computer software into experimental or control (standard of care) group, respectively:
Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned
to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both
groups will be followed by an ID physician on the research team with in-person or
telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital
discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient
satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months
using clinical (resolution of infection) and laboratory parameters (improvement in
inflammatory markers) and adverse events related to antimicrobial therapy/vascular access
complication. The following 3 secondary outcomes will be assessed: overall readmission at 3
months, readmission related to initial infection or antimicrobial therapy/vascular access
complication at 3 months, and patient satisfaction at 6 weeks. The experimental group is
being compared to standard of care in current clinical practice.
As this is a pragmatic clinical trial, patients will not undergo additional invasive testing
or procedures.