COPAT: Comparing Oral Versus Parenteral Antimicrobial Therapy

Sponsor

West Virginia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05977868

Collaborator

(none)

135

Enrollment

Location

Arms

Anticipated Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

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) 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.

Condition or Disease	Intervention/Treatment	Phase
Endovascular Infection Bone and Joint Infection Skin and Soft Tissue Infection Pulmonary Infection Gastrointestinal Infection Genitourinary Infection	Drug: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid Drug: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The primary outcome of cure at 3 months will be adjudicated by a 2 ID faculty blinded to study arm.

Primary Purpose:

Treatment

Official Title:

Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 (Experimental) COpAT (oral antimicrobial therapy) on hospital discharge	Drug: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid COpAT (oral antimicrobial therapy) on hospital discharge Other Names: metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole
Active Comparator: Group 2 (Control) Standard of care (IV antimicrobial therapy) on hospital discharge	Drug: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem Standard of care (IV antimicrobial therapy) on hospital discharge Other Names: meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin

Arm

Intervention/Treatment

Experimental: Group 1 (Experimental)

COpAT (oral antimicrobial therapy) on hospital discharge

Drug: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid

COpAT (oral antimicrobial therapy) on hospital discharge

Other Names:

metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole

Active Comparator: Group 2 (Control)

Standard of care (IV antimicrobial therapy) on hospital discharge

Drug: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem

Standard of care (IV antimicrobial therapy) on hospital discharge

Other Names:

meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin

Outcome Measures

Primary Outcome Measures

Cure at 3 months [3 months after hospital discharge]
Number of patients with cure using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters as adjudicated by 2 ID faculty blinded to study arm
Adverse events related to antimicrobial therapy/vascular access complication [Up to 3 months after hospital discharge]
Number of adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia) and/or vascular access complication (e.g., deep venous thrombosis)

Secondary Outcome Measures

Overall readmission at 3 months [Up to 3 months after hospital discharge]
Number of patients readmitted for any reason
Readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months [Up to 3 months after hospital discharge]
Number of patients readmitted for a reason related to initial infection or antimicrobial therapy/vascular access complication
Patient satisfaction [6 weeks after hospital discharge]
Patient satisfaction using the COPAT Trial Patient Satisfaction Survey at 6 Weeks, which is a short questionnaire (with some questions incorporating a Likert scale 0=worst, 5=best) designed to assess overall patient satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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