A Phase 4 interventional study of Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid and Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem in Endovascular Infection, Bone and Joint Infection and Skin and Soft Tissue Infection, sponsored by West Virginia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by West Virginia University · Phase 4, Interventional, and Treatment
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.
90 studies on the registry are indexed under Soft Tissue Infections; 11 are open to participants now.
This study's enrollment of 94 is below the median of 120 across 57 interventional studies indexed under Soft Tissue Infections.
Browse Soft Tissue Infections studies →West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion (may not meet any of the following):
COpAT (oral antimicrobial therapy) on hospital discharge
Drug: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid
Standard of care (IV antimicrobial therapy) on hospital discharge
Drug: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
COpAT (oral antimicrobial therapy) on hospital discharge
Also known as: metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole
Standard of care (IV antimicrobial therapy) on hospital discharge
Also known as: meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin
Cure/Control at 3 Months
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
Time frame: 3 months after hospital discharge
Adverse Events Related to Antimicrobial Therapy
Number of participants with adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia)
Time frame: Up to 3 months after hospital discharge
Adverse Events Related to Vascular Access
Number of participants with adverse events requiring intervention related to vascular access complication (e.g., deep venous thrombosis)
Time frame: Up to 3 months after hospital discharge
Overall Readmission
Number of participants readmitted for any reason up to 3 months after discharge from the hospital
Time frame: Up to 3 months after hospital discharge
Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey
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.
Time frame: 6 weeks after hospital discharge
Number of Participants Who Answered 'Yes' to the Survey Question "Would You Have Preferred to be in the Other Study Arm? (Yes or No)"
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").
Time frame: 6 weeks after hospital discharge
| Milestone | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Started | 64 | 30 |
| Completed | 62 | 28 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Transitioned to comfort care | 1 | 0 |
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
| Participants | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Cure/Control at 3 Months | 61 | 28 |
Number of participants with adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia)
| Participants | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Adverse Events Related to Antimicrobial Therapy | 4 | 4 |
Number of participants with adverse events requiring intervention related to vascular access complication (e.g., deep venous thrombosis)
| Participants | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Adverse Events Related to Vascular Access | 0 | 7 |
Number of participants readmitted for any reason up to 3 months after discharge from the hospital
| Participants | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Overall Readmission | 17 | 7 |
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.
| participants | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey | 60 | 27 |
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").
| participants | Group 1 (Experimental) | Group 2 (Control) |
|---|---|---|
| Number of Participants Who Answered 'Yes' to the Survey Question "Would You Have Preferred to be in the Other Study Arm? (Yes or No)" | 1 | 21 |
Collected over Until study completion, for a duration of up to three months after hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 1/64 (1.6%) | 18/64 (28.1%) | 4/64 (6.3%) |
| Control | 0/30 (0%) | 7/30 (23.3%) | 8/30 (26.7%) |
| Event | Experimental | Control |
|---|---|---|
| ReadmissionGeneral disorders | 7/64 | 2/30 |
| ReadmissionSurgical and medical procedures | 6/64 | 1/30 |
| ReadmissionCardiac disorders | 1/64 | 2/30 |
| ReadmissionInfections and infestations | 3/64 | 1/30 |
| ReadmissionRespiratory, thoracic and mediastinal disorders | 2/64 | 1/30 |
| ReadmissionVascular disorders | 0/64 | 1/30 |
| MortalityNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/64 | 0/30 |
| Event | Experimental | Control |
|---|---|---|
| Line Related Adverse EventVascular disorders | 0/64 | 7/30 |
| Antibiotic Side EffectGeneral disorders | 3/64 | 2/30 |
| Antibiotic Side EffectInfections and infestations | 1/64 | 1/30 |
| Antibiotic Side EffectRespiratory, thoracic and mediastinal disorders | 0/64 | 1/30 |
| Age, Continuous(years) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Median | 57.5 (49 to 69) | 61.5 (51.5 to 70) | 60 (50 to 70) |
| Sex: Female, Male(Participants) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Female | 25 | 8 | 33 |
| Male | 37 | 20 | 57 |
| Race and Ethnicity Not Collected(Participants) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| United States | 62 | 28 | 90 |
| Length of Hospital Stay(days) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Median | 8 (6 to 11) | 10 (7 to 11) | 9 (6 to 11) |
| Comorbidities(participants) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Obesity | 39 | 17 | 56 |
| Diabetes | 33 | 11 | 44 |
| Cardiac | 18 | 13 | 31 |
| Pulmonary | 10 | 5 | 15 |
| Renal | 6 | 0 | 6 |
| Infection Type(Participants) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Endovascular | 8 | 5 | 13 |
| Bone and Joint | 46 | 20 | 66 |
| Other | 8 | 3 | 11 |
| Bacteremia(Participants) | Group 1 (Experimental) | Group 2 (Control) | Total |
|---|---|---|---|
| Count of participants | 30 | 13 | 43 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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