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NCT05977868 · ClinicalTrials.gov registry record · Phase 4
Comparing Oral Versus Parenteral Antimicrobial Therapy
A Phase 4 study, sponsored by West Virginia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 94
- Enrollment target
NCT05977868 is a Phase 4 study that was terminated before completion, run by West Virginia University. The registered enrollment target is 94 participants.
The verdict
NCT05977868, a Phase 4 study, was terminated before completion, sponsored by West Virginia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 94 participants
- Enrollment target
Study 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.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2023-08-04 |
| Est. Completion | 2025-02-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05977868
The ClinicalTrials.gov registry entry for NCT05977868 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is West Virginia University, which has 122 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid is the first listed.
NCT05977868 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05977868 about?
NCT05977868 is a clinical study titled "Comparing Oral Versus Parenteral Antimicrobial Therapy". 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 d...
What is the current status of trial NCT05977868?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 94 participants. The study started on 2023-08-04. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT05977868?
The interventions under investigation include: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid (DRUG), Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem (DRUG).
Who is sponsoring clinical trial NCT05977868?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
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