xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977868</url>
    </required_header>
    <id_info>
      <org_study_id>2304754420</org_study_id>
      <nct_id>NCT05977868</nct_id>
    </id_info>
    <brief_title>Comparing Oral Versus Parenteral Antimicrobial Therapy</brief_title>
    <acronym>COPAT</acronym>
    <official_title>Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>West Virginia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West Virginia University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an investigator initiated multisite pragmatic randomized controlled trial designed to&#xD;
        demonstrate equivalent effectiveness with improved safety of early transition from&#xD;
        intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy&#xD;
        (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft&#xD;
        tissue, pulmonary, gastrointestinal, and genitourinary infections).&#xD;
  &#xD;
        All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be&#xD;
        evaluated by the research team with respect to inclusion/exclusion criteria. If determined&#xD;
        eligible for enrollment, patients will be approached by a study investigator who will present&#xD;
        the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using&#xD;
        computer software into experimental or control (standard of care) group, respectively:&#xD;
        Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned&#xD;
        to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both&#xD;
        groups will be followed by an ID physician on the research team with in-person or&#xD;
        telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital&#xD;
        discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient&#xD;
        satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months&#xD;
        using clinical (resolution of infection) and laboratory parameters (improvement in&#xD;
        inflammatory markers) and adverse events related to antimicrobial therapy/vascular access&#xD;
        complication. The following 3 secondary outcomes will be assessed: overall readmission at 3&#xD;
        months, readmission related to initial infection or antimicrobial therapy/vascular access&#xD;
        complication at 3 months, and patient satisfaction at 6 weeks. The experimental group is&#xD;
        being compared to standard of care in current clinical practice.&#xD;
  &#xD;
        As this is a pragmatic clinical trial, patients will not undergo additional invasive testing&#xD;
        or procedures.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The primary outcome of cure at 3 months will be adjudicated by a 2 ID faculty blinded to study arm.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cure at 3 months</measure>
      <time_frame>3 months after hospital discharge</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse events related to antimicrobial therapy/vascular access complication</measure>
      <time_frame>Up to 3 months after hospital discharge</time_frame>
      <description>Number of adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia) and/or vascular access complication (e.g., deep venous thrombosis)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall readmission at 3 months</measure>
      <time_frame>Up to 3 months after hospital discharge</time_frame>
      <description>Number of patients readmitted for any reason</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months</measure>
      <time_frame>Up to 3 months after hospital discharge</time_frame>
      <description>Number of patients readmitted for a reason related to initial infection or antimicrobial therapy/vascular access complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>6 weeks after hospital discharge</time_frame>
      <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</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">135</enrollment>
    <condition>Endovascular Infection</condition>
    <condition>Bone and Joint Infection</condition>
    <condition>Skin and Soft Tissue Infection</condition>
    <condition>Pulmonary Infection</condition>
    <condition>Gastrointestinal Infection</condition>
    <condition>Genitourinary Infection</condition>
    <arm_group>
      <arm_group_label>Group 1 (Experimental)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>COpAT (oral antimicrobial therapy) on hospital discharge</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (Control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard of care (IV antimicrobial therapy) on hospital discharge</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid</intervention_name>
      <description>COpAT (oral antimicrobial therapy) on hospital discharge</description>
      <arm_group_label>Group 1 (Experimental)</arm_group_label>
      <other_name>metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem</intervention_name>
      <description>Standard of care (IV antimicrobial therapy) on hospital discharge</description>
      <arm_group_label>Group 2 (Control)</arm_group_label>
      <other_name>meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion (must meet all of the following):&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  The patient is hospitalized at J.W. Ruby Memorial Hospital, United Hospital Center,&#xD;
               Berkeley Medical Center, Wheeling Hospital, or Camden Clark Medical Center&#xD;
  &#xD;
            -  The patient has been diagnosed with ≥1 of the following: endovascular, bone and joint,&#xD;
               skin and soft tissue, pulmonary, gastrointestinal, or genitourinary infection&#xD;
  &#xD;
            -  The patient is being transitioned to 2-8 weeks of IV antibacterial therapy on hospital&#xD;
               discharge&#xD;
  &#xD;
            -  The patient has capacity to participate in routine OPAT/COpAT follow-up (telephone&#xD;
               check-ins, laboratory monitoring, and in-person or telemedicine ID Clinic follow-up)&#xD;
  &#xD;
          Exclusion (may not meet any of the following):&#xD;
  &#xD;
            -  The patient is not appropriate for OPAT (active injection drug use, lack of infusion&#xD;
               resources, and/or unstable outpatient environment)&#xD;
  &#xD;
            -  The patient is not appropriate for COpAT (unable to receive PO medication or lack of&#xD;
               an effective PO antimicrobial option based on susceptibility testing)&#xD;
  &#xD;
            -  The patient is unable to give informed consent&#xD;
  &#xD;
            -  The patient is a prisoner, pregnant, and/or mentally handicapped&#xD;
  &#xD;
            -  The patient is determined unsafe for enrollment at the primary team's discretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joy J. Juskowich, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>West Virginia University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Arif R. Sarwari, MD, MSc, MBA</last_name>
      <role>Principal Investigator</role>
      <affiliation>West Virginia University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joy J. Juskowich, MD</last_name>
      <phone>304-293-3306</phone>
      <phone_ext>3</phone_ext>
      <email>jjuskowi@hsc.wvu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Arif R. Sarwari, MD, MSc, MBA</last_name>
      <phone>304-293-3306</phone>
      <phone_ext>3</phone_ext>
      <email>asarwari@hsc.wvu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>West Virginia University</name>
        <address>
          <city>Morgantown</city>
          <state>West Virginia</state>
          <zip>26506</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joy J. Juskowich, MD</last_name>
        <phone>304-293-3306</phone>
        <phone_ext>3</phone_ext>
        <email>jjuskowi@hsc.wvu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Arif R. Sarwari, MD, MSc, MBA</last_name>
        <phone>304-293-3306</phone>
        <phone_ext>3</phone_ext>
        <email>asarwari@hsc.wvu.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Joy J. Juskowich, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arif R. Sarwari, MD, MSc, MBA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>30152252</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30699315</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35139280</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35439822</PMID>
    </reference>
    <reference>
      <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</citation>
    </reference>
    <reference>
      <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</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36881940</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>West Virginia University</investigator_affiliation>
      <investigator_full_name>Joy Juskowich</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>COpAT</keyword>
    <keyword>Oral antimicrobial therapy</keyword>
    <keyword>OPAT</keyword>
    <keyword>Parenteral antimicrobial therapy</keyword>
    <keyword>Intravenous antimicrobial therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Soft Tissue Infections</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Amoxicillin</mesh_term>
      <mesh_term>Moxifloxacin</mesh_term>
      <mesh_term>Metronidazole</mesh_term>
      <mesh_term>Vancomycin</mesh_term>
      <mesh_term>Doxycycline</mesh_term>
      <mesh_term>Ciprofloxacin</mesh_term>
      <mesh_term>Levofloxacin</mesh_term>
      <mesh_term>Rifampin</mesh_term>
      <mesh_term>Meropenem</mesh_term>
      <mesh_term>Cefazolin</mesh_term>
      <mesh_term>Tazobactam</mesh_term>
      <mesh_term>Linezolid</mesh_term>
      <mesh_term>Piperacillin</mesh_term>
      <mesh_term>Clavulanic Acid</mesh_term>
      <mesh_term>Daptomycin</mesh_term>
      <mesh_term>Penicillins</mesh_term>
      <mesh_term>Ceftazidime</mesh_term>
      <mesh_term>Cephalexin</mesh_term>
      <mesh_term>Ampicillin</mesh_term>
      <mesh_term>Ertapenem</mesh_term>
      <mesh_term>Cefepime</mesh_term>
      <mesh_term>Tigecycline</mesh_term>
      <mesh_term>Ceftaroline fosamil</mesh_term>
      <mesh_term>Trimethoprim, Sulfamethoxazole Drug Combination</mesh_term>
      <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
      <mesh_term>Piperacillin, Tazobactam Drug Combination</mesh_term>
      <mesh_term>Avibactam</mesh_term>
      <mesh_term>Sulbactam</mesh_term>
      <mesh_term>Dalbavancin</mesh_term>
      <mesh_term>Oritavancin</mesh_term>
      <mesh_term>Avibactam, ceftazidime drug combination</mesh_term>
      <mesh_term>Oxacillin</mesh_term>
      <mesh_term>Cefadroxil</mesh_term>
      <mesh_term>Cefpodoxime</mesh_term>
      <mesh_term>Sultamicillin</mesh_term>
      <mesh_term>Trimethoprim</mesh_term>
      <mesh_term>Sulfamethoxazole</mesh_term>
      <mesh_term>Delafloxacin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977868
  org study id: 2304754420
  nct id: NCT05977868
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  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.
  measure: Cure at 3 months
  time frame: 3 months after hospital discharge
  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
  measure: Adverse events related to antimicrobial therapy/vascular access complication
  time frame: Up to 3 months after hospital discharge
  description: Number of adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia) and/or vascular access complication (e.g., deep venous thrombosis)
  measure: Overall readmission at 3 months
  time frame: Up to 3 months after hospital discharge
  description: Number of patients readmitted for any reason
  measure: Readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months
  time frame: Up to 3 months after hospital discharge
  description: Number of patients readmitted for a reason related to initial infection or antimicrobial therapy/vascular access complication
  measure: Patient satisfaction
  time frame: 6 weeks after hospital discharge
  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
  arm group label: Group 1 (Experimental)
  arm group type: Experimental
  description: COpAT (oral antimicrobial therapy) on hospital discharge
  arm group label: Group 2 (Control)
  arm group type: Active Comparator
  description: Standard of care (IV antimicrobial therapy) on hospital discharge
  intervention type: Drug
  intervention name: Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid
  description: COpAT (oral antimicrobial therapy) on hospital discharge
  arm group label: Group 1 (Experimental)
  other name: metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole
  intervention type: Drug
  intervention name: Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
  description: Standard of care (IV antimicrobial therapy) on hospital discharge
  arm group label: Group 2 (Control)
  other name: meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joy J. Juskowich, MD
  role: Principal Investigator
  affiliation: West Virginia University
  last name: Arif R. Sarwari, MD, MSc, MBA
  role: Principal Investigator
  affiliation: West Virginia University
  last name: Joy J. Juskowich, MD
  phone: 304-293-3306
  phone ext: 3
  email: jjuskowi@hsc.wvu.edu
  last name: Arif R. Sarwari, MD, MSc, MBA
  phone: 304-293-3306
  phone ext: 3
  email: asarwari@hsc.wvu.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  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.
  PMID: 30152252
  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.
  PMID: 30699315
  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.
  PMID: 35139280
  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.
  PMID: 35439822
  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
  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
  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.
  PMID: 36881940
  responsible party type: Principal Investigator
  investigator affiliation: West Virginia University
  investigator full name: Joy Juskowich
  investigator title: Assistant Professor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Soft Tissue Infections
  mesh term: Amoxicillin
  mesh term: Moxifloxacin
  mesh term: Metronidazole
  mesh term: Vancomycin
  mesh term: Doxycycline
  mesh term: Ciprofloxacin
  mesh term: Levofloxacin
  mesh term: Rifampin
  mesh term: Meropenem
  mesh term: Cefazolin
  mesh term: Tazobactam
  mesh term: Linezolid
  mesh term: Piperacillin
  mesh term: Clavulanic Acid
  mesh term: Daptomycin
  mesh term: Penicillins
  mesh term: Ceftazidime
  mesh term: Cephalexin
  mesh term: Ampicillin
  mesh term: Ertapenem
  mesh term: Cefepime
  mesh term: Tigecycline
  mesh term: Ceftaroline fosamil
  mesh term: Trimethoprim, Sulfamethoxazole Drug Combination
  mesh term: Amoxicillin-Potassium Clavulanate Combination
  mesh term: Piperacillin, Tazobactam Drug Combination
  mesh term: Avibactam
  mesh term: Sulbactam
  mesh term: Dalbavancin
  mesh term: Oritavancin
  mesh term: Avibactam, ceftazidime drug combination
  mesh term: Oxacillin
  mesh term: Cefadroxil
  mesh term: Cefpodoxime
  mesh term: Sultamicillin
  mesh term: Trimethoprim
  mesh term: Sulfamethoxazole
  mesh term: Delafloxacin
  sharing ipd: No