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 (improvement in inflammatory markers) parameters and adverse events related to antimicrobial therapy/vascular access complication or readmission at 3 months. The following secondary outcome will be assessed: 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
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14
• Results First Submitted: 2025-06-26
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Results First Posted: 2025-08-26
• Last Update Posted: 2025-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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/Control at 3 Months	3 months after hospital discharge	Number of patients with cure/control 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	Up to 3 months after hospital discharge	Number of participants with adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia)
Adverse Events Related to Vascular Access	Up to 3 months after hospital discharge	Number of participants with adverse events requiring intervention related to vascular access complication (e.g., deep venous thrombosis)
Overall Readmission	Up to 3 months after hospital discharge	Number of participants readmitted for any reason up to 3 months after discharge from the hospital

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey	6 weeks after hospital discharge	Patient satisfaction using the COPAT Trial Patient Satisfaction Survey at 6 Weeks, which is a short questionnaire (with the overall satisfaction question incorporating a Likert scale 1= Very Dissatisfied, 5= Very Satisfied) designed to assess overall patient satisfaction. Overall satisfaction totaled from participants answering 4= Satisfied and 5= Very Satisfied.
Number of Participants Who Answered 'Yes' to the Survey Question "Would You Have Preferred to be in the Other Study Arm? (Yes or No)"	6 weeks after hospital discharge	The number of participants who expressed a preference to be in the other study arm (i.e., answers 'Yes' to the survey question "Would you have preferred to be in the other study arm? Yes or No").

Trial Locations

Locations (1)

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