<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/NCT04414137</url>
  </required_header>
  <id_info>
    <org_study_id>19-283</org_study_id>
    <nct_id>NCT04414137</nct_id>
  </id_info>
  <brief_title>Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin</brief_title>
  <official_title>Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide,&#xD;
      concentration-dependent. Its spectrum concerns Gram-positive bacteria.&#xD;
&#xD;
      Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary&#xD;
      eosinophilia associated with its use have been reported in Europe and worldwide.&#xD;
&#xD;
      The purpose of this study is to describe the mechanism of occurrence of this AE with dapto;&#xD;
      Prolonged exposure and accumulation at the alveolar level could potentially have a role.&#xD;
      Better understanding the mechanisms of appearance of this AE would provide predictive&#xD;
      elements making it possible to limit the occurrence of this AE in the future&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide,&#xD;
      concentration-dependent. Its spectrum concerns Gram-positive bacteria.&#xD;
&#xD;
      The Infectious Diseases Society of America recommends the use of daptomycin 6 mg / kg / day&#xD;
      in the second-line treatment of IOA on staphylococcal but also enterococcal prostheses, as an&#xD;
      alternative to vancomycin and linezolid.&#xD;
&#xD;
      In case of renal failure, daptomycin is often considered as a good therapeutic alternative to&#xD;
      glycopeptides.&#xD;
&#xD;
      Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary&#xD;
      eosinophilia associated with its use have been reported in Europe and worldwide. Although a&#xD;
      large proportion of cases have been reported in patients receiving daptomycin in unapproved&#xD;
      indications, the use of daptomycin in authorized indications has also been associated with&#xD;
      this risk.&#xD;
&#xD;
      The dosage of daptomycin makes it possible to evaluate its effectiveness and prevent the&#xD;
      occurrence of a overdose, provider of side effects.&#xD;
&#xD;
      The purpose of this study is to describe the mechanism of occurrence of this AE with dapto;&#xD;
      Prolonged exposure and accumulation at the alveolar level could potentially have a role.&#xD;
      Better understanding the mechanisms of appearance of this AE would provide predictive&#xD;
      elements making it possible to limit the occurrence of this AE in the future&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin</measure>
    <time_frame>2 months</time_frame>
    <description>description of the BJI/PJI (symptoms, type of evolution, type of implant)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description patients having eosinophilic pneumonia due to daptomycin</measure>
    <time_frame>2 months</time_frame>
    <description>description of the patients (average age, medical background)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event</measure>
    <time_frame>6 months</time_frame>
    <description>number of cases and description of the adverse event as assessed by CTCAE v4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine</measure>
    <time_frame>6 months</time_frame>
    <description>description of the use of daptomycine : dosage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine</measure>
    <time_frame>6 months</time_frame>
    <description>description of the use of daptomycine : duration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance</measure>
    <time_frame>6 months</time_frame>
    <description>mean daptomycine plasma clearance (unit, liters per hour)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution</measure>
    <time_frame>6 months</time_frame>
    <description>mean daptomycine volume of distribution (unit, liters)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dactinomycin Adverse Reaction</condition>
  <condition>Bone and Joint Infection</condition>
  <arm_group>
    <arm_group_label>Eosinophilic pneumonia on daptomycin</arm_group_label>
    <description>patients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Description of eosinophilic pneumonia due to daptomycine</intervention_name>
    <description>Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection</description>
    <arm_group_label>Eosinophilic pneumonia on daptomycin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having had an eosinophilic pneumonia under daptomycine given to treat an&#xD;
        osteoarticular infection (BJI/PJI) treated at the CRIOAc Lyon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients having had an eosinophilic pneumonia under daptomycine given to treat an&#xD;
             osteoarticular infection (BJI/PJI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Eugénie Mabrut, CRA</last_name>
    <phone>04 26 73 29 38</phone>
    <email>eugenie.mabrut@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tristan Ferry, Md,PhD</last_name>
    <phone>04 26 73 29 38</phone>
    <email>tristan.ferry@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eugenie Mabrut, CRA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.crioac-lyon.fr/</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eosinophilic pneumonia</keyword>
  <keyword>Daptomycin</keyword>
  <keyword>Bone and joint infection</keyword>
  <keyword>Adverse event</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pulmonary Eosinophilia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Daptomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04414137
org study id: 19-283
nct id: NCT04414137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide,
      concentration-dependent. Its spectrum concerns Gram-positive bacteria.

      Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary
      eosinophilia associated with its use have been reported in Europe and worldwide.

      The purpose of this study is to describe the mechanism of occurrence of this AE with dapto;
      Prolonged exposure and accumulation at the alveolar level could potentially have a role.
      Better understanding the mechanisms of appearance of this AE would provide predictive
      elements making it possible to limit the occurrence of this AE in the future
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide,
      concentration-dependent. Its spectrum concerns Gram-positive bacteria.

      The Infectious Diseases Society of America recommends the use of daptomycin 6 mg / kg / day
      in the second-line treatment of IOA on staphylococcal but also enterococcal prostheses, as an
      alternative to vancomycin and linezolid.

      In case of renal failure, daptomycin is often considered as a good therapeutic alternative to
      glycopeptides.

      Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary
      eosinophilia associated with its use have been reported in Europe and worldwide. Although a
      large proportion of cases have been reported in patients receiving daptomycin in unapproved
      indications, the use of daptomycin in authorized indications has also been associated with
      this risk.

      The dosage of daptomycin makes it possible to evaluate its effectiveness and prevent the
      occurrence of a overdose, provider of side effects.

      The purpose of this study is to describe the mechanism of occurrence of this AE with dapto;
      Prolonged exposure and accumulation at the alveolar level could potentially have a role.
      Better understanding the mechanisms of appearance of this AE would provide predictive
      elements making it possible to limit the occurrence of this AE in the future
observational model: Cohort
time perspective: Retrospective
measure: description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin
time frame: 2 months
description: description of the BJI/PJI (symptoms, type of evolution, type of implant)
measure: description patients having eosinophilic pneumonia due to daptomycin
time frame: 2 months
description: description of the patients (average age, medical background)
measure: rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event
time frame: 6 months
description: number of cases and description of the adverse event as assessed by CTCAE v4.0
measure: Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine
time frame: 6 months
description: description of the use of daptomycine : dosage
measure: Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine
time frame: 6 months
description: description of the use of daptomycine : duration
measure: Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance
time frame: 6 months
description: mean daptomycine plasma clearance (unit, liters per hour)
measure: Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution
time frame: 6 months
description: mean daptomycine volume of distribution (unit, liters)
arm group label: Eosinophilic pneumonia on daptomycin
description: patients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia
intervention type: Other
intervention name: Description of eosinophilic pneumonia due to daptomycine
description: Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection
arm group label: Eosinophilic pneumonia on daptomycin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
last name: Eugénie Mabrut, CRA
phone: 04 26 73 29 38
email: eugenie.mabrut@chu-lyon.fr
last name: Tristan Ferry, Md,PhD
phone: 04 26 73 29 38
email: tristan.ferry@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
url: http://www.crioac-lyon.fr/
description: Related Info
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pulmonary Eosinophilia
mesh term: Daptomycin
sharing ipd: Undecided