<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/NCT04482231</url>
  </required_header>
  <id_info>
    <org_study_id>BAROMETRE</org_study_id>
    <nct_id>NCT04482231</nct_id>
  </id_info>
  <brief_title>Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases</brief_title>
  <acronym>AORD</acronym>
  <official_title>Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</source>
  <oversight_info>
    <has_dmc>Yes</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>
      the study aimed to determine the distribution of respiratory infections in Tunisian&#xD;
      population and evaluate the frequency of antibiotics prescribed according to current&#xD;
      international recommendations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is an observational, cross-sectional, multicenter, national clinical study . The study was&#xD;
      carried out from January 2018 to August 2018 in Tunisian population involving 57 primary care&#xD;
      outpatient centers and 6 emergency departments from the 24 departments of the country .&#xD;
&#xD;
      We included all patients with lower and upper respiratory tract infections (RTIs) who have&#xD;
      recieved antibiotic treatment.&#xD;
&#xD;
      Lower respiratory tract infection (LRTI) include pneumonia and acute bronchitis.&#xD;
&#xD;
      Acute upper respiratory tract infection (URTIs) include rhinitis, pharyngitis/tonsillitis,&#xD;
      and laryngitis. Rhinitis, also known as coryza, is irritation and inflammation of the mucous&#xD;
      membrane inside the nose.&#xD;
&#xD;
      The protocol of our study includes the demographic characteristics and the history of the&#xD;
      sample as well as the symptomatology at inclusion. The data from the clinical examination&#xD;
      were reported by the investigating doctor. After the diagnosis retained by the doctor is&#xD;
      noted with the management of the patient which includes additional explorations if they have&#xD;
      been requested. Finally, the investigating doctor specifies the antibiotic therapy&#xD;
      prescribed.Appropriateness of antibiotic prescription was assessed in patients managed in the&#xD;
      EDs . We used the MAI score (medication appropriateness index) wich includes 10 criteria. For&#xD;
      each criterion, the evaluator rates whether the medication is appropriate, marginally&#xD;
      appropriate, or inappropriate. Support is provided through explicit definitions and&#xD;
      instructions.The MAI has been used in observational and interventional studies.Its&#xD;
      feasibility, content validity, predictive validity, and reliability have been demonstrated in&#xD;
      ambulatory settings. The maximum score is 20 which translates into maximum inappropriateness.&#xD;
      If a patient is on multiple drugs, this test can be repeated for each drug in order to&#xD;
      determine a total MAI score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Appropriateness of antibiotic prescription</measure>
    <time_frame>1 day</time_frame>
    <description>dichotomous (yes / no) criterion that characterizes appropriate or inappropriate use of antibiotics based on respiratory indication and patient profile</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inappropriatness of antibiotic prescription</measure>
    <time_frame>1 day</time_frame>
    <description>number of inappropriate antibiotic prescriptions by clinical indication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>international recommendations</measure>
    <time_frame>1 day</time_frame>
    <description>description of therapeutic strategies inconsistent with international recommendations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients profile with inappropriate antibiotic therapy</measure>
    <time_frame>1 day</time_frame>
    <description>profile of patients with inappropriate antibiotic therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients profile with infectious disease</measure>
    <time_frame>1 day</time_frame>
    <description>profile of patients with infectious disease</description>
  </secondary_outcome>
  <enrollment type="Actual">9944</enrollment>
  <condition>Antibiotic Sore Tongue</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The protocol includes the demographics, history, and the symptomatology at inclusion. After&#xD;
        the diagnosis retained by the doctor is noted and specifies the antibiotic therapy&#xD;
        prescribed.Appropriateness of antibiotic prescription was assessed in patients managed in&#xD;
        the EDs. We used the MAI score (medication appropriateness index) wich includes 10&#xD;
        criteria. For each criterion, the evaluator rates whether the medication is appropriate,&#xD;
        marginally appropriate, or inappropriate.If a patient is on multiple drugs, this test can&#xD;
        be repeated for each drug.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with lower and upper RTIs who recieved antibiotic treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not obtained informed consent, specific respiratory infection such as tuberculosis,&#xD;
             life-threatening emergency necessitating hospitalization or non-probabilistic&#xD;
             antibiotic therapy and contraindication to antibiotic use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>nouira semir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency department of fattouma bourguiba university hospital</name>
      <address>
        <city>Monastir</city>
        <zip>5020</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>professor semir nouira</investigator_title>
  </responsible_party>
  <keyword>antiobiotic,</keyword>
  <keyword>respiratory tract infections</keyword>
  <keyword>appropriateness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_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/NCT04482231
org study id: BAROMETRE
nct id: NCT04482231
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the study aimed to determine the distribution of respiratory infections in Tunisian
      population and evaluate the frequency of antibiotics prescribed according to current
      international recommendations.
It is an observational, cross-sectional, multicenter, national clinical study . The study was
      carried out from January 2018 to August 2018 in Tunisian population involving 57 primary care
      outpatient centers and 6 emergency departments from the 24 departments of the country .

      We included all patients with lower and upper respiratory tract infections (RTIs) who have
      recieved antibiotic treatment.

      Lower respiratory tract infection (LRTI) include pneumonia and acute bronchitis.

      Acute upper respiratory tract infection (URTIs) include rhinitis, pharyngitis/tonsillitis,
      and laryngitis. Rhinitis, also known as coryza, is irritation and inflammation of the mucous
      membrane inside the nose.

      The protocol of our study includes the demographic characteristics and the history of the
      sample as well as the symptomatology at inclusion. The data from the clinical examination
      were reported by the investigating doctor. After the diagnosis retained by the doctor is
      noted with the management of the patient which includes additional explorations if they have
      been requested. Finally, the investigating doctor specifies the antibiotic therapy
      prescribed.Appropriateness of antibiotic prescription was assessed in patients managed in the
      EDs . We used the MAI score (medication appropriateness index) wich includes 10 criteria. For
      each criterion, the evaluator rates whether the medication is appropriate, marginally
      appropriate, or inappropriate. Support is provided through explicit definitions and
      instructions.The MAI has been used in observational and interventional studies.Its
      feasibility, content validity, predictive validity, and reliability have been demonstrated in
      ambulatory settings. The maximum score is 20 which translates into maximum inappropriateness.
      If a patient is on multiple drugs, this test can be repeated for each drug in order to
      determine a total MAI score.
observational model: Other
time perspective: Cross-Sectional
measure: Appropriateness of antibiotic prescription
time frame: 1 day
description: dichotomous (yes / no) criterion that characterizes appropriate or inappropriate use of antibiotics based on respiratory indication and patient profile
measure: inappropriatness of antibiotic prescription
time frame: 1 day
description: number of inappropriate antibiotic prescriptions by clinical indication
measure: international recommendations
time frame: 1 day
description: description of therapeutic strategies inconsistent with international recommendations
measure: patients profile with inappropriate antibiotic therapy
time frame: 1 day
description: profile of patients with inappropriate antibiotic therapy
measure: patients profile with infectious disease
time frame: 1 day
description: profile of patients with infectious disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: nouira semir, MD
role: Principal Investigator
affiliation: University of Monastir
facility: 
country: Tunisia
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: professor semir nouira
mesh term: Tuberculosis
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: No