Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT)
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ClinicalTrials.gov Identifier: NCT05977868 |
Recruitment Status :
Enrolling by invitation
First Posted : August 7, 2023
Last Update Posted : December 12, 2023
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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 Type : | Interventional (Clinical Trial) |
Estimated 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 |
Actual Study Start Date : | August 4, 2023 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
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Experimental: Group 1 (Experimental)
COpAT (oral antimicrobial therapy) on hospital discharge
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Drug: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid
COpAT (oral antimicrobial therapy) on hospital discharge
Other Name: metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole |
Active Comparator: Group 2 (Control)
Standard of care (IV antimicrobial therapy) on hospital discharge
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Drug: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
Standard of care (IV antimicrobial therapy) on hospital discharge
Other Name: meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin |
- Cure at 3 months [ Time Frame: 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 [ Time Frame: 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)
- Overall readmission at 3 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977868
United States, West Virginia | |
West Virginia University | |
Morgantown, West Virginia, United States, 26506 |
Principal Investigator: | Joy J. Juskowich, MD | West Virginia University | |
Principal Investigator: | Arif R. Sarwari, MD, MSc, MBA | West Virginia University |
Responsible Party: | Joy J. Juskowich, MD, Assistant Professor, West Virginia University |
ClinicalTrials.gov Identifier: | NCT05977868 |
Other Study ID Numbers: |
2304754420 |
First Posted: | August 7, 2023 Key Record Dates |
Last Update Posted: | December 12, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COpAT Oral antimicrobial therapy OPAT Parenteral antimicrobial therapy Intravenous antimicrobial therapy |
Infections Communicable Diseases Soft Tissue Infections Disease Attributes Pathologic Processes Amoxicillin Moxifloxacin Metronidazole Vancomycin Doxycycline Levofloxacin Ciprofloxacin Rifampin Meropenem Cefazolin |
Tazobactam Linezolid Piperacillin Clavulanic Acid Penicillins Daptomycin Ceftazidime Cephalexin Ampicillin Cefepime Ertapenem Ceftaroline Tigecycline Trimethoprim, Sulfamethoxazole Drug Combination Piperacillin, Tazobactam Drug Combination |