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Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT)

Primary Purpose

Endovascular Infection, Bone and Joint Infection, Skin and Soft Tissue Infection

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endovascular Infection focused on measuring COpAT, Oral antimicrobial therapy, OPAT, Parenteral antimicrobial therapy, Intravenous antimicrobial therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (Experimental)

Group 2 (Control)

Arm Description

COpAT (oral antimicrobial therapy) on hospital discharge

Standard of care (IV antimicrobial therapy) on hospital discharge

Outcomes

Primary Outcome Measures

Cure at 3 months
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
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

Overall readmission at 3 months
Number of patients readmitted for any reason
Readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months
Number of patients readmitted for a reason related to initial infection or antimicrobial therapy/vascular access complication
Patient satisfaction
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

Full Information

First Posted
July 14, 2023
Last Updated
July 24, 2023
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT05977868
Brief Title
Comparing Oral Versus Parenteral Antimicrobial Therapy
Acronym
COPAT
Official Title
Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endovascular Infection, Bone and Joint Infection, Skin and Soft Tissue Infection, Pulmonary Infection, Gastrointestinal Infection, Genitourinary Infection
Keywords
COpAT, Oral antimicrobial therapy, OPAT, Parenteral antimicrobial therapy, Intravenous antimicrobial therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The primary outcome of cure at 3 months will be adjudicated by a 2 ID faculty blinded to study arm.
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Experimental)
Arm Type
Experimental
Arm Description
COpAT (oral antimicrobial therapy) on hospital discharge
Arm Title
Group 2 (Control)
Arm Type
Active Comparator
Arm Description
Standard of care (IV antimicrobial therapy) on hospital discharge
Intervention Type
Drug
Intervention Name(s)
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid
Other Intervention Name(s)
metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole
Intervention Description
COpAT (oral antimicrobial therapy) on hospital discharge
Intervention Type
Drug
Intervention Name(s)
Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
Other Intervention Name(s)
meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin
Intervention Description
Standard of care (IV antimicrobial therapy) on hospital discharge
Primary Outcome Measure Information:
Title
Cure at 3 months
Description
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
Time Frame
3 months after hospital discharge
Title
Adverse events related to antimicrobial therapy/vascular access complication
Description
Number of adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia) and/or vascular access complication (e.g., deep venous thrombosis)
Time Frame
Up to 3 months after hospital discharge
Secondary Outcome Measure Information:
Title
Overall readmission at 3 months
Description
Number of patients readmitted for any reason
Time Frame
Up to 3 months after hospital discharge
Title
Readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months
Description
Number of patients readmitted for a reason related to initial infection or antimicrobial therapy/vascular access complication
Time Frame
Up to 3 months after hospital discharge
Title
Patient satisfaction
Description
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
Time Frame
6 weeks after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joy J. Juskowich, MD
Phone
304-293-3306
Ext
3
Email
jjuskowi@hsc.wvu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arif R. Sarwari, MD, MSc, MBA
Phone
304-293-3306
Ext
3
Email
asarwari@hsc.wvu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy J. Juskowich, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arif R. Sarwari, MD, MSc, MBA
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy J. Juskowich, MD
Phone
304-293-3306
Ext
3
Email
jjuskowi@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Arif R. Sarwari, MD, MSc, MBA
Phone
304-293-3306
Ext
3
Email
asarwari@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Joy J. Juskowich, MD
First Name & Middle Initial & Last Name & Degree
Arif R. Sarwari, MD, MSc, MBA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30152252
Citation
Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, Bruun NE, Hofsten DE, Fursted K, Christensen JJ, Schultz M, Klein CF, Fosboll EL, Rosenvinge F, Schonheyder HC, Kober L, Torp-Pedersen C, Helweg-Larsen J, Tonder N, Moser C, Bundgaard H. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28.
Results Reference
background
PubMed Identifier
30699315
Citation
Li HK, Rombach I, Zambellas R, Walker AS, McNally MA, Atkins BL, Lipsky BA, Hughes HC, Bose D, Kumin M, Scarborough C, Matthews PC, Brent AJ, Lomas J, Gundle R, Rogers M, Taylor A, Angus B, Byren I, Berendt AR, Warren S, Fitzgerald FE, Mack DJF, Hopkins S, Folb J, Reynolds HE, Moore E, Marshall J, Jenkins N, Moran CE, Woodhouse AF, Stafford S, Seaton RA, Vallance C, Hemsley CJ, Bisnauthsing K, Sandoe JAT, Aggarwal I, Ellis SC, Bunn DJ, Sutherland RK, Barlow G, Cooper C, Geue C, McMeekin N, Briggs AH, Sendi P, Khatamzas E, Wangrangsimakul T, Wong THN, Barrett LK, Alvand A, Old CF, Bostock J, Paul J, Cooke G, Thwaites GE, Bejon P, Scarborough M; OVIVA Trial Collaborators. Oral versus Intravenous Antibiotics for Bone and Joint Infection. N Engl J Med. 2019 Jan 31;380(5):425-436. doi: 10.1056/NEJMoa1710926.
Results Reference
background
PubMed Identifier
35139280
Citation
Pries-Heje MM, Wiingaard C, Ihlemann N, Gill SU, Bruun NE, Elming H, Povlsen JA, Madsen T, Jensen KT, Fursted K, Schultz M, Ostergaard L, Christensen JJ, Christiansen U, Rosenvinge F, Helweg-Larsen J, Fosbol EL, Kober L, Torp-Pedersen C, Tonder N, Moser C, Iversen K, Bundgaard H. Five-Year Outcomes of the Partial Oral Treatment of Endocarditis (POET) Trial. N Engl J Med. 2022 Feb 10;386(6):601-602. doi: 10.1056/NEJMc2114046. No abstract available.
Results Reference
background
PubMed Identifier
35439822
Citation
Staples JA, Ho M, Ferris D, Hayek J, Liu G, Tran KC, Sutherland JM. Outpatient Versus Inpatient Intravenous Antimicrobial Therapy: A Population-Based Observational Cohort Study of Adverse Events and Costs. Clin Infect Dis. 2022 Nov 30;75(11):1921-1929. doi: 10.1093/cid/ciac298.
Results Reference
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Citation
Rivera CG, Mehta M, Ryan KL, Stevens RW, Tucker KJ, Mahoney MV. Role of infectious diseases pharmacists in outpatient intravenous and complex oral antimicrobial therapy: Society of Infectious Diseases Pharmacists insights. J Am Coll Clin Pharm. 2021;4:1161-1169. doi: 10.1002/jac5.1473
Results Reference
background
Citation
Juskowich JJ, Ward A, Spigelmyer AE, Howard CA, Slain D, Guilfoose JA, Edmond MB, Sarwari AR. Complex Outpatient Oral Antimicrobial Therapy (COpAT) Program at a Rural Academic Medical Center: Evaluation of First 100 Patients. Open Forum Infect Dis. 2022; 9(2): S418-S419. doi: 10.1093/ofid/ofac492.843
Results Reference
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PubMed Identifier
36881940
Citation
Freling S, Wald-Dickler N, Banerjee J, Canamar CP, Tangpraphaphorn S, Bruce D, Davar K, Dominguez F, Norwitz D, Krishnamurthi G, Fung L, Guanzon A, Minejima E, Spellberg M, Spellberg C, Baden R, Holtom P, Spellberg B. Real-World Application of Oral Therapy for Infective Endocarditis: A Multicenter, Retrospective, Cohort Study. Clin Infect Dis. 2023 Sep 11;77(5):672-679. doi: 10.1093/cid/ciad119.
Results Reference
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Comparing Oral Versus Parenteral Antimicrobial Therapy

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