<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/NCT03256474</url>
  </required_header>
  <id_info>
    <org_study_id>PKA_01</org_study_id>
    <nct_id>NCT03256474</nct_id>
  </id_info>
  <brief_title>Managing Bacterial Pneumonia in Children Without Antimicrobials</brief_title>
  <official_title>Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ARCIM Institute Academic Research in Complementary and Integrative Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ARCIM Institute Academic Research in Complementary and Integrative Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective cohort analysis of children hospitalized for pneumonia comparing disease&#xD;
      severity on admission, clinical course, treatment and outcomes and prospective telephone&#xD;
      based Follow-Up assessement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a retrospective cohort analysis of children hospitalized for&#xD;
      pneumonia at the Filderklinik between December 2006 and November 2010. The Bacterial&#xD;
      Pneumonia Score, a validated composite laboratory, clinical and radiologic score developed by&#xD;
      Moreno et al, will be retrospectively applied to define cases as either viral or bacterial&#xD;
      pneumonia. The investigators will compare disease severity on admission, clinical course, and&#xD;
      outcomes (in terms of complications, length of stay and readmission rates) between&#xD;
      antimicrobial and non-antimicrobial managed bacterial pneumonia cases. Long-term Follow-Up&#xD;
      will be assessed by telephone interviews with the parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">February 25, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>Cure rate of non-antimicrobial management of bacterial pneumonia</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Cure rate of non-antimicrobial management of bacterial pneumonia (in the following and in the final publication, the term &quot;bacterial pneumonia&quot; will be used for children who fulfill the Moreno criteria for pneumonia): % of children managed without antimicrobials since admission, without subsequent need for antimicrobials or readmission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical complication rate</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>7 - 10 years after hospitalization</time_frame>
    <description>Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature normalization</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Days to temperature normalization (&lt; 38°C) in children with bacterial pneumonia, managed with or without antimicrobials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Days of supplemental oxygen need</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory rate</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in respiratory rate as an indicator for pulmonary infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Bacterial Pneumonia Score</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in oxygen saturation</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in oxygen saturation as an indicator for pulmonary infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CRP</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in CRP as an indicator for infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leukocyte count</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in leukocyte count as an indicator for infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pH</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in pH as an indicator for respiratory distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pCO2</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Changes in pCO2 as an indicator for respiratory distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of chronic and acute-infectious co-morbidities</measure>
    <time_frame>Day of admission</time_frame>
    <description>Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utilization rate of a package of complementary treatment measures</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Utilization rate of a package of complementary treatment measures from anthroposophic medicine (including oral medications, inhalation and external nursing applications) in children managed with or without antimicrobials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antimicrobial treatment rate in children with viral pneumonia</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients treated with antipyretics</measure>
    <time_frame>Between admission and 3 months after discharge</time_frame>
    <description>Number of patients treated with antipyretics</description>
  </secondary_outcome>
  <enrollment type="Actual">350</enrollment>
  <condition>Pneumonia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimodal Therapy</intervention_name>
    <description>Drugs, external applications like chest wraps, inhalations</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for&#xD;
        pneumonia treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital admission at the pediatric department of the Filderklinik.&#xD;
&#xD;
          -  Admission diagnosis pneumonia (ICD J12.0, J12.1, J12.8, J12.9, J14, J15.1, J15.6,&#xD;
             J15.7, J15.8, J15.9, J16.8, J18.0, J18.1, J18.8, J18.9 - all 12s, 15s, 16s, 18s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arcim Institute</name>
      <address>
        <city>Filderstadt</city>
        <state>Baden-Württemberg</state>
        <zip>70794</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</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>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Bacterial</mesh_term>
  </condition_browse>
  <!-- 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/NCT03256474
org study id: PKA_01
nct id: NCT03256474
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Retrospective cohort analysis of children hospitalized for pneumonia comparing disease
      severity on admission, clinical course, treatment and outcomes and prospective telephone
      based Follow-Up assessement.
The investigators will conduct a retrospective cohort analysis of children hospitalized for
      pneumonia at the Filderklinik between December 2006 and November 2010. The Bacterial
      Pneumonia Score, a validated composite laboratory, clinical and radiologic score developed by
      Moreno et al, will be retrospectively applied to define cases as either viral or bacterial
      pneumonia. The investigators will compare disease severity on admission, clinical course, and
      outcomes (in terms of complications, length of stay and readmission rates) between
      antimicrobial and non-antimicrobial managed bacterial pneumonia cases. Long-term Follow-Up
      will be assessed by telephone interviews with the parents.
observational model: Cohort
time perspective: Retrospective
measure: Cure rate of non-antimicrobial management of bacterial pneumonia
time frame: Between admission and 3 months after discharge
description: Cure rate of non-antimicrobial management of bacterial pneumonia (in the following and in the final publication, the term "bacterial pneumonia" will be used for children who fulfill the Moreno criteria for pneumonia): % of children managed without antimicrobials since admission, without subsequent need for antimicrobials or readmission.
measure: Medical complication rate
time frame: Between admission and 3 months after discharge
description: Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
measure: Length of hospital stay
time frame: Between admission and 3 months after discharge
description: Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
measure: Readmission rate
time frame: 7 - 10 years after hospitalization
description: Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
measure: Temperature normalization
time frame: Between admission and 3 months after discharge
description: Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
measure: Days of supplemental oxygen need
time frame: Between admission and 3 months after discharge
description: Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials
measure: Changes in respiratory rate
time frame: Between admission and 3 months after discharge
description: Changes in respiratory rate as an indicator for pulmonary infection
measure: Changes in Bacterial Pneumonia Score
time frame: Between admission and 3 months after discharge
description: Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection
measure: Changes in oxygen saturation
time frame: Between admission and 3 months after discharge
description: Changes in oxygen saturation as an indicator for pulmonary infection
measure: Changes in CRP
time frame: Between admission and 3 months after discharge
description: Changes in CRP as an indicator for infection
measure: Changes in leukocyte count
time frame: Between admission and 3 months after discharge
description: Changes in leukocyte count as an indicator for infection
measure: Changes in pH
time frame: Between admission and 3 months after discharge
description: Changes in pH as an indicator for respiratory distress
measure: Changes in pCO2
time frame: Between admission and 3 months after discharge
description: Changes in pCO2 as an indicator for respiratory distress
measure: Rate of chronic and acute-infectious co-morbidities
time frame: Day of admission
description: Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials
measure: Utilization rate of a package of complementary treatment measures
time frame: Between admission and 3 months after discharge
description: Utilization rate of a package of complementary treatment measures from anthroposophic medicine (including oral medications, inhalation and external nursing applications) in children managed with or without antimicrobials
measure: Antimicrobial treatment rate in children with viral pneumonia
time frame: Between admission and 3 months after discharge
description: Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score
measure: Number of patients treated with antipyretics
time frame: Between admission and 3 months after discharge
description: Number of patients treated with antipyretics
intervention type: Other
intervention name: Multimodal Therapy
description: Drugs, external applications like chest wraps, inhalations
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Bacterial