<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/NCT03761953</url>
  </required_header>
  <id_info>
    <org_study_id>831334</org_study_id>
    <nct_id>NCT03761953</nct_id>
  </id_info>
  <brief_title>Oritavancin for Staphylococcus Aureus Infections in Opioid Users</brief_title>
  <official_title>A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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 will be a pilot single-arm study consisting of 15 participants evaluating the use of&#xD;
      oritavancin in the final consolidation phase (last two weeks of treatment) of systemic&#xD;
      infections with Staphylococcus aureus (S. aureus) in opioid users.&#xD;
&#xD;
      The purpose of this pilot proposal is to collect information for a subsequent large,&#xD;
      randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2)&#xD;
      Duration of hospitalization and rate of recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be an early phase, single center, open label pilot study of 15 participants&#xD;
      designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or&#xD;
      Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections&#xD;
      refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and&#xD;
      exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks&#xD;
      of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for&#xD;
      IE. Participants will be evaluated weekly until completion of treatment and then at week 4&#xD;
      and week 6 after the infusion of oritavancin. Participants will have blood drawn at each&#xD;
      visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by&#xD;
      culture for the presence of relapse of the infection. At the last visit, participants will&#xD;
      have an echocardiogram.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVID 19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">March 24, 2022</completion_date>
  <primary_completion_date type="Actual">March 24, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This will be a pilot single-arm study consisting of 15 patients evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of relapse of infection</measure>
    <time_frame>6 weeks</time_frame>
    <description>Efficacy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>6 weeks</time_frame>
    <description>Duration of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse of systemic S. aureus infections</measure>
    <time_frame>6 weeks</time_frame>
    <description>Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Staphylococcus Aureus Bacteremia</condition>
  <condition>Staphylococcus Aureus Endocarditis</condition>
  <arm_group>
    <arm_group_label>Oritavancin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single IV infusion of 1200mg of oritavancin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oritavancin Injection</intervention_name>
    <description>single 1200mg infusion of IV oritavancin.</description>
    <arm_group_label>Oritavancin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  Systemic infection with S. aureus&#xD;
&#xD;
          -  Afebrile for &gt;48 hours&#xD;
&#xD;
          -  Negative blood cultures for at least 48 hours&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) equal or greater 750/mm3&#xD;
&#xD;
          -  Hemoglobin &gt; 9.0 g/dL&#xD;
&#xD;
          -  Platelet count equal or &gt; 50,000/mm3&#xD;
&#xD;
          -  Creatinine &lt; 2.0 x ULN&#xD;
&#xD;
          -  AST ; ALT, and alkaline phosphatase &lt; 2.0 x ULN&#xD;
&#xD;
          -  Willing to use a medically accepted method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Require valve replacement surgery&#xD;
&#xD;
          -  Have prosthetic material in body (This includes prosthetic heart valves and/or&#xD;
             prosthetic joints)&#xD;
&#xD;
          -  Septic emboli to central nervous system or lungs&#xD;
&#xD;
          -  Breast feeding during entire participation&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Polymicrobial infection&#xD;
&#xD;
          -  Require anticoagulation&#xD;
&#xD;
          -  Allergy to vancomycin or oritavancin&#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>Pablo Tebas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trials Unit. University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104--607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Staphylococcal Infections</mesh_term>
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Endocarditis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oritavancin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03761953
org study id: 831334
nct id: NCT03761953
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This will be a pilot single-arm study consisting of 15 participants evaluating the use of
      oritavancin in the final consolidation phase (last two weeks of treatment) of systemic
      infections with Staphylococcus aureus (S. aureus) in opioid users.

      The purpose of this pilot proposal is to collect information for a subsequent large,
      randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2)
      Duration of hospitalization and rate of recurrence.
This will be an early phase, single center, open label pilot study of 15 participants
      designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or
      Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections
      refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and
      exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks
      of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for
      IE. Participants will be evaluated weekly until completion of treatment and then at week 4
      and week 6 after the infusion of oritavancin. Participants will have blood drawn at each
      visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by
      culture for the presence of relapse of the infection. At the last visit, participants will
      have an echocardiogram.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a pilot single-arm study consisting of 15 patients evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin
time frame: 6 weeks
description: Safety
measure: Frequency of relapse of infection
time frame: 6 weeks
description: Efficacy
measure: Duration of hospitalization
time frame: 6 weeks
description: Duration of hospitalization
measure: Relapse of systemic S. aureus infections
time frame: 6 weeks
description: Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures
measure: Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)
time frame: 6 weeks
description: Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin
measure: Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
time frame: 6 weeks
description: Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18)
arm group label: Oritavancin
arm group type: Experimental
description: Single IV infusion of 1200mg of oritavancin
intervention type: Drug
intervention name: Oritavancin Injection
description: single 1200mg infusion of IV oritavancin.
arm group label: Oritavancin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pablo Tebas, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Staphylococcal Infections
mesh term: Bacteremia
mesh term: Endocarditis
mesh term: Oritavancin
sharing ipd: No