Comparing Oral Versus Parenteral Antimicrobial Therapy

Phase 4

Terminated

• Conditions: Gastrointestinal Infection; Endovascular Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Bone and Joint Infection; Genitourinary Infection
• Interventions: 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

• Registration Number: NCT05977868
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-24
• Study Start: 2023-08-04
• Study First Posted: 2023-08-07
• Status Verified: 2025-02
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Experimental)	Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid	COpAT (oral antimicrobial therapy) on hospital discharge
Group 2 (Control)	Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem	Standard of care (IV antimicrobial therapy) on hospital discharge

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States