<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/NCT01714596</url>
  </required_header>
  <id_info>
    <org_study_id>METRC POvIV</org_study_id>
    <nct_id>NCT01714596</nct_id>
  </id_info>
  <brief_title>Randomized Trial to Assess PO Versus IV Antibiotics</brief_title>
  <acronym>POvIV</acronym>
  <official_title>A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Major Extremity Trauma Research Consortium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Major Extremity Trauma Research Consortium</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the effect of treatment of post-op wound infection in&#xD;
      long bones after fracture fixation or joint fusion and either: (Group 1) operative&#xD;
      debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and&#xD;
      IV antibiotics for 6 weeks.&#xD;
&#xD;
      Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in&#xD;
      Group 1 will be non-inferior to the rate in Group 2.&#xD;
&#xD;
      Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be&#xD;
      non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that&#xD;
      require surgery &gt;2 weeks after initial debridement, infection recurrence, infection with a&#xD;
      new pathogen, joint erosion, implant failure, medical problems related to the treatment&#xD;
      administration which necessitates a switch from one arm to the other.&#xD;
&#xD;
      Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection,&#xD;
      non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2.&#xD;
&#xD;
      Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment&#xD;
      costs at 1 year will be lower in Group 1 than in Group 2.&#xD;
&#xD;
      Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2.&#xD;
&#xD;
      Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior&#xD;
      to adherence in Group 2.&#xD;
&#xD;
      Specific Aim 2: To build and validate a risk prediction model for failure of treatment of&#xD;
      early post-op wound infections after fixation of fractures and joint fusions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2013</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study injury related surgical interventions by 1 year</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment Failure by 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Treatment failure is defined as wound problems that require surgery &gt;2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-hospitalizations by 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Re-hospitalization for complications, such as infection, non-union and amputation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare costs</measure>
    <time_frame>1 year</time_frame>
    <description>Cost of PO versus IV medications include medical record and bill abstracted costs associated with outpatient clinic visits, home health visits, medication, subsequent hospital readmission, and other types of medical care as identified over the course of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>1 year</time_frame>
    <description>Patient adherence to PO and IV medications&#xD;
Patient adherence with PO antibiotics will be monitored through wireless-enabled microchip monitors embedded in pill bottles by the Medication Event Monitoring System (MEMS) and weekly adherence questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Patient satisfaction with treatment measured by Short Form Patient Satisfaction Questionnaire (PSQ-18)&#xD;
The PSQ-18 measures 6 domains: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility. A score of 0.8 or higher in each domain correlates with improved satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">233</enrollment>
  <condition>Wound Infection</condition>
  <arm_group>
    <arm_group_label>Oral Antibiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV Antibiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PO versus IV antibiotics Route of administration evaluation</intervention_name>
    <description>This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.</description>
    <arm_group_label>IV Antibiotic</arm_group_label>
    <arm_group_label>Oral Antibiotic</arm_group_label>
    <other_name>based on local practices and bacterial susceptibilities</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with any fractures of any bone at or proximal to and including the&#xD;
             tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal&#xD;
             radius fractures), excluding the spine, treated with any type of internal fixation, or&#xD;
&#xD;
          2. Patients undergoing fusion of any bone at or proximal to and including the subtalar&#xD;
             joint or radial carpal joint, (excluding the spine) that develop a post op wound&#xD;
             infection at any time.&#xD;
&#xD;
          3. Patients diagnosed with a wound infection of the study injury, defined as patients&#xD;
             with at least one of the following:&#xD;
&#xD;
               1. Deep culture positive after operative debridement.&#xD;
&#xD;
               2. Cultures positive in thio only after operative debridement.&#xD;
&#xD;
               3. Negative culture after operative debridement if wound infection meets the Center&#xD;
                  for Disease control and Prevention (CDC) criteria.&#xD;
&#xD;
          4. Patients who are English or Spanish competent.&#xD;
&#xD;
          5. Patients aged 18 - 84.&#xD;
&#xD;
          6. Patients with bacteria susceptible to both PO and IV antibiotics.&#xD;
&#xD;
          7. Patients able to be treated for their infection at the METRC facility for at least 12&#xD;
             months following definitive surgical procedure&#xD;
&#xD;
          8. Patients may have multiple eligible study-eligible injuries.&#xD;
&#xD;
          9. Patients may have temporary external fixation prior to definitive fixation.&#xD;
&#xD;
         10. Patients may have received antibiotics prior to operative wound debridement.&#xD;
&#xD;
         11. Patient is able to obtain study medication(s).&#xD;
&#xD;
         12. Patient may be pregnant at the time of screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have high risk of amputation of the study limb (based on opinion of the&#xD;
             initial managing physician).&#xD;
&#xD;
          2. Patients undergoing treatment with any other investigational therapy within the month&#xD;
             preceding implantation or planned within the 12 months following implantation.&#xD;
&#xD;
          3. Patients with history of chronic infection at the site of study injury, defined as:&#xD;
&#xD;
             patients with chronic osteomyelitis identified by radiographic erosion or sequestrum;&#xD;
             or patients with more than one instance of surgical treatment of infection and&#xD;
             approximately 6 week course of antibiotics.&#xD;
&#xD;
          4. Patients with pathological fractures; a known history of Paget's disease.&#xD;
&#xD;
          5. Patients for whom the definitive treatment of the study injury was an external&#xD;
             fixator.&#xD;
&#xD;
          6. Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication&#xD;
             (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA&#xD;
&#xD;
          7. Patients with cultures positive in thio only.&#xD;
&#xD;
          8. Patients who are incarcerated or who have unstable housing situations due to concerns&#xD;
             regarding ability to receive home care, adherence phone calls, and maintain follow up.&#xD;
             .&#xD;
&#xD;
          9. Patients or designated proxy who are unwilling to provide consent.&#xD;
&#xD;
         10. Patients with a history of IV drug use who in the investigator's opinion are&#xD;
             unsuitable candidates for IV therapy.&#xD;
&#xD;
         11. Patients likely to have severe problems maintaining follow-up, including patients&#xD;
             diagnosed with a severe psychiatric conditions, patients who live too far outside the&#xD;
             hospital's catchment area.&#xD;
&#xD;
         12. Patients with traumatic brain injury or who are intellectually challenged and who lack&#xD;
             adequate family support to ensure adherence to the protocol.&#xD;
&#xD;
         13. Patients unable to swallow oral medications or without adequately functioning GI&#xD;
             tract.&#xD;
&#xD;
         14. Patients who, based upon the clinical judgment of the treating clinician, are NOT&#xD;
             equally suited for treatment with either oral or intravenous antibiotics (i.e., those&#xD;
             for whom there is a clinical treatment preference).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William T Obremskey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renan Castillo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tara Taylor, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Ryder Trauma Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eskenazi Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals &amp; Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland R Adams Cowley Shock Trauma Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis University Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jamaica Hospital Medical Center</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State University M.S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center (SAMMC)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Center Portsmouth</name>
      <address>
        <city>Portsmouth</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington/Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>April 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Antibiotic</keyword>
  <keyword>Intravenous Antibiotic</keyword>
  <keyword>Wound infection</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01714596
org study id: METRC POvIV
nct id: NCT01714596
lead sponsor: 
has dmc: Yes
The goal of this study is to evaluate the effect of treatment of post-op wound infection in
      long bones after fracture fixation or joint fusion and either: (Group 1) operative
      debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and
      IV antibiotics for 6 weeks.

      Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in
      Group 1 will be non-inferior to the rate in Group 2.

      Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be
      non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that
      require surgery >2 weeks after initial debridement, infection recurrence, infection with a
      new pathogen, joint erosion, implant failure, medical problems related to the treatment
      administration which necessitates a switch from one arm to the other.

      Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection,
      non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2.

      Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment
      costs at 1 year will be lower in Group 1 than in Group 2.

      Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2.

      Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior
      to adherence in Group 2.

      Specific Aim 2: To build and validate a risk prediction model for failure of treatment of
      early post-op wound infections after fixation of fractures and joint fusions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Study injury related surgical interventions by 1 year
time frame: 1 year
measure: Treatment Failure by 1 year
time frame: 1 year
description: Treatment failure is defined as wound problems that require surgery >2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other.
measure: Re-hospitalizations by 1 year
time frame: 1 year
description: Re-hospitalization for complications, such as infection, non-union and amputation
measure: Healthcare costs
time frame: 1 year
description: Cost of PO versus IV medications include medical record and bill abstracted costs associated with outpatient clinic visits, home health visits, medication, subsequent hospital readmission, and other types of medical care as identified over the course of the study.
measure: Medication Adherence
time frame: 1 year
description: Patient adherence to PO and IV medications
Patient adherence with PO antibiotics will be monitored through wireless-enabled microchip monitors embedded in pill bottles by the Medication Event Monitoring System (MEMS) and weekly adherence questionnaire.
measure: Satisfaction with treatment
time frame: 1 year
description: Patient satisfaction with treatment measured by Short Form Patient Satisfaction Questionnaire (PSQ-18)
The PSQ-18 measures 6 domains: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility. A score of 0.8 or higher in each domain correlates with improved satisfaction.
arm group label: Oral Antibiotic
arm group type: Active Comparator
description: Oral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician.
arm group label: IV Antibiotic
arm group type: Active Comparator
description: Participants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician.
intervention type: Other
intervention name: PO versus IV antibiotics Route of administration evaluation
description: This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
arm group label: IV Antibiotic
arm group label: Oral Antibiotic
other name: based on local practices and bacterial susceptibilities
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: William T Obremskey, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Renan Castillo, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
last name: Tara Taylor, MPH
role: Study Director
affiliation: Johns Hopkins Bloomberg School of Public Health
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Wound Infection
mesh term: Anti-Bacterial Agents