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/NCT06023550</url>
    </required_header>
    <id_info>
      <org_study_id>ENT infections</org_study_id>
      <nct_id>NCT06023550</nct_id>
    </id_info>
    <brief_title>Complicated Infections in Otorhinolaryngology</brief_title>
    <acronym>ENT_infect</acronym>
    <official_title>Analysis of Complicated Infections in Pediatric and Adult Populations Treated by Otorhinolaryngologist</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Centre Ljubljana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Medical Centre Ljubljana</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>
        This observational study aims to learn more about complicated infections treated by&#xD;
        otorhinolaryngologists. The main questions to answer are:&#xD;
  &#xD;
          -  What is the management of complicated sinonasal infections in Ljubljana, Slovenia,&#xD;
  &#xD;
          -  What is the management of complicated ear and temporal bone infections in Ljubljana,&#xD;
             Slovenia,&#xD;
  &#xD;
          -  What is the management of complicated neck soft tissue infections in Ljubljana,&#xD;
             Slovenia,&#xD;
  &#xD;
          -  What is the management of complicated laryngeal infections in Ljubljana, Slovenia&#xD;
  &#xD;
        Participants will receive standard treatment according to the established evidence-based&#xD;
        clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main purpose of the research is to obtain own data on the treatment of patients with&#xD;
        infections in ENT areas that require targeted treatment by an otolaryngologist at the&#xD;
        hospital level. Based on these results, treatment outcome would be improved and&#xD;
        hospitalization time would be shortened. We would establish clinical pathways for the&#xD;
        treatment of these diseases in Slovenia. There is still no data on the treatment of these&#xD;
        diseases in ENT departments in Slovenia, so one of the main purposes of the research is to&#xD;
        obtain objective indicators of the success of treatment in comparison with other countries&#xD;
        and a rough epidemiological assessment of the disease in Slovenia.&#xD;
  &#xD;
        The research would establish a database of patients with complicated infections in ENT areas&#xD;
        at the University Clinical Center Ljubljana, which would be used for prospective analysis&#xD;
        even after the research was completed. The register would also enable transparency in the&#xD;
        treatment of these patients in the future.&#xD;
  &#xD;
        The main questions to answer are:&#xD;
  &#xD;
          -  What is the management of complicated sinonasal infections in Ljubljana, Slovenia,&#xD;
  &#xD;
          -  What is the management of complicated ear and temporal bone infections in Ljubljana,&#xD;
             Slovenia,&#xD;
  &#xD;
          -  What is the management of complicated neck soft tissue infections in Ljubljana,&#xD;
             Slovenia,&#xD;
  &#xD;
          -  What is the management of complicated laryngeal infections in Ljubljana, Slovenia&#xD;
  &#xD;
        Participants will receive standard treatment according to the established evidence-based&#xD;
        clinical practice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2028</completion_date>
    <primary_completion_date type="Anticipated">September 2027</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Disease free survival</measure>
      <time_frame>12 months</time_frame>
      <description>Number of living patients without a disease</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">2550</enrollment>
    <condition>Sinusitis</condition>
    <condition>Otitis</condition>
    <condition>Laryngitis</condition>
    <condition>Lymphadenitis</condition>
    <condition>Quinsy</condition>
    <condition>Peritonsillar Abscess</condition>
    <condition>Parapharyngeal Abscess</condition>
    <condition>Preseptal Cellulitis</condition>
    <condition>Subperiosteal Abscess</condition>
    <condition>Orbital Abscess</condition>
    <condition>Epiglottitis</condition>
    <arm_group>
      <arm_group_label>Complicated sinonasal infection</arm_group_label>
      <description>Group of patients with a complicated sinonasal infection, including local or systemic complications.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Complicated ear or temporal bone infection</arm_group_label>
      <description>Group of patients with a complicated ear or temporal bone infection, including local or systemic complications.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Complicated neck soft tissue infection</arm_group_label>
      <description>Group of patients with a complicated neck soft tissue infection, including local or systemic complications.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Complicated laryngeal infection</arm_group_label>
      <description>Group of patients with a complicated laryngeal infection, including local or systemic complications.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment with surgery and/or conservative measures</intervention_name>
      <description>Patients will be treated according to established clinical practice with surgery and/or conservative measures.</description>
      <arm_group_label>Complicated ear or temporal bone infection</arm_group_label>
      <arm_group_label>Complicated laryngeal infection</arm_group_label>
      <arm_group_label>Complicated neck soft tissue infection</arm_group_label>
      <arm_group_label>Complicated sinonasal infection</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with complicated infections treated by otorhinolaryngologists in the tertiary&#xD;
          otorhinolaryngology referral centre.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnoses: rhinitis AND/OR sinusitis AND/OR facial cellulitis AND/OR facial abscess&#xD;
               AND/OR nasal furuncle AND/OR infection of the outer AND/OR middle AND/OR inner ear&#xD;
               AND/OR temporal bone AND/OR infection of the soft tissues of the neck with/without&#xD;
               bone and cartilage involvement AND/OR laryngitis AND/OR epiglottitis (or&#xD;
               supraglottitis) AND/OR&#xD;
  &#xD;
            -  complication of inflammation of the nose and paranasal cavities AND/OR ear AND/OR&#xD;
               temporal bone AND/OR:&#xD;
  &#xD;
            -  treated at the Department of Otorhinolaryngology and Cervicofacial Surgery, University&#xD;
               Medical Center Ljubljana.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  disagreement of the patient and/or parents (or legal guardians) with inclusion in the&#xD;
               research,&#xD;
  &#xD;
            -  failure to meet the inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Domen Vozel, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Domen Vozel, MD, PhD</last_name>
      <phone>+38615223280</phone>
      <email>domen.vozel@kclj.si</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Medical Centre Ljubljana</name>
        <address>
          <city>Ljubljana</city>
          <zip>1000</zip>
          <country>Slovenia</country>
        </address>
      </facility>
      <contact>
        <last_name>Domen Vozel, MD, PhD</last_name>
        <email>domen.vozel@kclj.si</email>
      </contact>
    </location>
    <location_countries>
      <country>Slovenia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
      <investigator_full_name>Domen Vozel, MD, PhD</investigator_full_name>
      <investigator_title>Domen Vozel, MD, PhD, ENT specialist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abscess</mesh_term>
      <mesh_term>Sinusitis</mesh_term>
      <mesh_term>Cellulitis</mesh_term>
      <mesh_term>Laryngitis</mesh_term>
      <mesh_term>Peritonsillar Abscess</mesh_term>
      <mesh_term>Epiglottitis</mesh_term>
      <mesh_term>Lymphadenitis</mesh_term>
    </condition_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/NCT06023550
  org study id: ENT infections
  nct id: NCT06023550
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational study aims to learn more about complicated infections treated by
        otorhinolaryngologists. The main questions to answer are:
  
          -  What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
  
          -  What is the management of complicated ear and temporal bone infections in Ljubljana,
             Slovenia,
  
          -  What is the management of complicated neck soft tissue infections in Ljubljana,
             Slovenia,
  
          -  What is the management of complicated laryngeal infections in Ljubljana, Slovenia
  
        Participants will receive standard treatment according to the established evidence-based
        clinical practice.
  The main purpose of the research is to obtain own data on the treatment of patients with
        infections in ENT areas that require targeted treatment by an otolaryngologist at the
        hospital level. Based on these results, treatment outcome would be improved and
        hospitalization time would be shortened. We would establish clinical pathways for the
        treatment of these diseases in Slovenia. There is still no data on the treatment of these
        diseases in ENT departments in Slovenia, so one of the main purposes of the research is to
        obtain objective indicators of the success of treatment in comparison with other countries
        and a rough epidemiological assessment of the disease in Slovenia.
  
        The research would establish a database of patients with complicated infections in ENT areas
        at the University Clinical Center Ljubljana, which would be used for prospective analysis
        even after the research was completed. The register would also enable transparency in the
        treatment of these patients in the future.
  
        The main questions to answer are:
  
          -  What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
  
          -  What is the management of complicated ear and temporal bone infections in Ljubljana,
             Slovenia,
  
          -  What is the management of complicated neck soft tissue infections in Ljubljana,
             Slovenia,
  
          -  What is the management of complicated laryngeal infections in Ljubljana, Slovenia
  
        Participants will receive standard treatment according to the established evidence-based
        clinical practice.
  observational model: Cohort
  time perspective: Prospective
  measure: Disease free survival
  time frame: 12 months
  description: Number of living patients without a disease
  arm group label: Complicated sinonasal infection
  description: Group of patients with a complicated sinonasal infection, including local or systemic complications.
  arm group label: Complicated ear or temporal bone infection
  description: Group of patients with a complicated ear or temporal bone infection, including local or systemic complications.
  arm group label: Complicated neck soft tissue infection
  description: Group of patients with a complicated neck soft tissue infection, including local or systemic complications.
  arm group label: Complicated laryngeal infection
  description: Group of patients with a complicated laryngeal infection, including local or systemic complications.
  intervention type: Other
  intervention name: Treatment with surgery and/or conservative measures
  description: Patients will be treated according to established clinical practice with surgery and/or conservative measures.
  arm group label: Complicated ear or temporal bone infection
  arm group label: Complicated laryngeal infection
  arm group label: Complicated neck soft tissue infection
  arm group label: Complicated sinonasal infection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Domen Vozel, MD, PhD
  role: Principal Investigator
  affiliation: Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana
  last name: Domen Vozel, MD, PhD
  phone: +38615223280
  email: domen.vozel@kclj.si
  facility: 
  contact: 
  country: Slovenia
  responsible party type: Principal Investigator
  investigator affiliation: University Medical Centre Ljubljana
  investigator full name: Domen Vozel, MD, PhD
  investigator title: Domen Vozel, MD, PhD, ENT specialist
  mesh term: Abscess
  mesh term: Sinusitis
  mesh term: Cellulitis
  mesh term: Laryngitis
  mesh term: Peritonsillar Abscess
  mesh term: Epiglottitis
  mesh term: Lymphadenitis
  sharing ipd: No