<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/NCT04496024</url>
  </required_header>
  <id_info>
    <org_study_id>PI2019_843_0018</org_study_id>
    <nct_id>NCT04496024</nct_id>
  </id_info>
  <brief_title>Ofloxacin Concentration-toxicity Relationship in the Elderly</brief_title>
  <acronym>ROSCO</acronym>
  <official_title>Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to&#xD;
      sensible staphylococcus strains. However, in the elderly, inter-individual variability of the&#xD;
      pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin&#xD;
      side effects is likely to be increased in case of higher exposition. However, the serum&#xD;
      concentration-toxicity relationship has not yet been determined. The purpose of this project&#xD;
      is to assess the association between the residual serum concentration of ofloxacin at day 3&#xD;
      and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a&#xD;
      threshold toxicity concentration if this association exists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections</measure>
    <time_frame>day 3</time_frame>
    <description>Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections</description>
  </primary_outcome>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Ofloxacin</condition>
  <condition>Bone and Joint Infection</condition>
  <condition>Therapeutic Drug Monitoring</condition>
  <condition>Adverse Drug Reactions</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ofloxacin</intervention_name>
    <description>ofloxacin treatment in patients with bone and joint infections</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42</description>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ofloxacin Serum concentration</intervention_name>
    <description>Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 65 years hospitalized at the University Hospital of Amiens for an&#xD;
             uncomplicated bone and joint infections&#xD;
&#xD;
          -  Indication for oral switch to ofloxacin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusing to participate in the study&#xD;
&#xD;
          -  Patient under guardianship or curators or deprived of public rights&#xD;
&#xD;
          -  Any liver or biliary injury&#xD;
&#xD;
          -  Any contraindications to ofloxacin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Youssef BENNIS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean Philippe LANOIX, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Youssef BENNIS, MD</last_name>
    <phone>(33)32208700</phone>
    <email>bennis.youssef@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youssef Bennis, MD</last_name>
      <phone>03 22 08 70 00</phone>
      <email>bennis.youssef@chu-amiens.fr</email>
    </contact>
    <investigator>
      <last_name>Jean Philippe LANOIX, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Luc SCHMIT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Youssef EL SAMAD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benoît BRUNSCHWEILER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ofloxacin</keyword>
  <keyword>Bone and Joint Infection</keyword>
  <keyword>therapeutic drug monitoring</keyword>
  <keyword>Adverse Drug Reactions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ofloxacin</mesh_term>
    <mesh_term>Levofloxacin</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/NCT04496024
org study id: PI2019_843_0018
nct id: NCT04496024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to
      sensible staphylococcus strains. However, in the elderly, inter-individual variability of the
      pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin
      side effects is likely to be increased in case of higher exposition. However, the serum
      concentration-toxicity relationship has not yet been determined. The purpose of this project
      is to assess the association between the residual serum concentration of ofloxacin at day 3
      and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a
      threshold toxicity concentration if this association exists.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
time frame: day 3
description: Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections
intervention type: Drug
intervention name: ofloxacin
description: ofloxacin treatment in patients with bone and joint infections
intervention type: Other
intervention name: questionnaire
description: questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42
intervention type: Biological
intervention name: Ofloxacin Serum concentration
description: Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Youssef BENNIS, MD
role: Principal Investigator
affiliation: CHU Amiens
last name: Jean Philippe LANOIX, MD
role: Study Chair
affiliation: CHU Amiens
last name: Youssef BENNIS, MD
phone: (33)32208700
email: bennis.youssef@chu-amiens.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Arthritis, Infectious
mesh term: Drug-Related Side Effects and Adverse Reactions
mesh term: Ofloxacin
mesh term: Levofloxacin
sharing ipd: No