<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/NCT01683487</url>
  </required_header>
  <id_info>
    <org_study_id>MM-CAP</org_study_id>
    <nct_id>NCT01683487</nct_id>
  </id_info>
  <brief_title>Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.</brief_title>
  <official_title>Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Analysis of Risk Factors and Impact on the Outcome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      I. To investigate time measurement from emergency room admission to first antibiotic&#xD;
      administration.&#xD;
&#xD;
      II. To evaluate risk factors for prolonged time to first antibiotic administration.&#xD;
&#xD;
      III. To correlate time measurement with Charlson comorbidity index and multimorbidity&#xD;
      patterns.&#xD;
&#xD;
      IV. To investigate the impact of a delayed time to first antibiotic administration on the&#xD;
      outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this retrospective cohort study, we plan to include all patients presenting with a&#xD;
      community-acquired pneumococcal pneumonia at the University Hospital of Zurich between&#xD;
      January 1, 2006 and June 30, 2012 (6½ years). The patients will be identified either with one&#xD;
      or more blood culture pairs positive for S. pneumoniae or with a positive pneumococcal urine&#xD;
      antigen assay in combination with the clinical diagnosis of CAP, which was based on the&#xD;
      presence of select clinical features (e.g., cough, fever, sputum production, and pleuritic&#xD;
      chest pain) and is supported by imaging of the lung, usually by chest radiography according&#xD;
      to Infectious Diseases Society of America/American Thoracic Society consensus guidelines on&#xD;
      the management of CAP in adults [11].&#xD;
&#xD;
      CAP is not considered if the patient is discharged from a hospital less than 7 days before&#xD;
      the current hospital admission, if the first blood culture or urinary antigen assay is&#xD;
      obtained more than 1 week after hospital admission, or if the patient has no clinical&#xD;
      diagnosis of CAP at the time of admission. Patients referred from or transferred to another&#xD;
      hospital are excluded.&#xD;
&#xD;
      After identification of eligible patients upon microbiological results, medical records are&#xD;
      reviewed using a standardized data collection questionnaire. Comorbidity is determined using&#xD;
      the Charlson comorbidity index [10]. Additionally, all patients are classified according to&#xD;
      the multimorbidity patterns proposed by Holden et al. [12]. These are:&#xD;
&#xD;
        1. arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;&#xD;
&#xD;
        2. asthma, chronic obstructive pulmonary disease, and allergies;&#xD;
&#xD;
        3. back/neck pain, migraine, other chronic pain, and arthritis;&#xD;
&#xD;
        4. high blood pressure, high cholesterol, obesity, diabetes, and fatigue;&#xD;
&#xD;
        5. cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and&#xD;
           arthritis; and&#xD;
&#xD;
        6. irritable bowel, ulcer, heartburn, and other chronic pain.&#xD;
&#xD;
      Time calculation is based upon the moment of emergency room (ER) admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>In-hospital mortaliy</measure>
    <time_frame>From day of admission until discharge or dead</time_frame>
    <description>Mortality during hospitalization because of pneumococcal pneumonia</description>
  </primary_outcome>
  <enrollment type="Actual">122</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>Observational study only, no intervention.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted and treated at the University Hospital of Zurich because of severe&#xD;
        community-acquired pneumococcal pneumonia requiring hospilazation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria: Patients with community-acquired pneumococcal pneumonia, which was&#xD;
        confirmed by&#xD;
&#xD;
          1. detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum&#xD;
             OR/AND&#xD;
&#xD;
          2. positive urinary pneumococcal antigen AND&#xD;
&#xD;
          3. presence of cough and presence of one of the following signs/symptoms: new focal chest&#xD;
             signs; dyspnoea; tachypnoea; fever AND&#xD;
&#xD;
          4. radiologic signs of pneumonia&#xD;
&#xD;
        Exclusion criteria: - Pneumonia of other cause (e.g. non-pneumococcal pneumonia)&#xD;
&#xD;
          -  Hospital-acquired or ventilator-associated pneumonia&#xD;
&#xD;
          -  Patients referred from or transferred to another hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Franzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Internal Medicine</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>May 26, 2014</last_update_submitted>
  <last_update_submitted_qc>May 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</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, Pneumococcal</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/NCT01683487
org study id: MM-CAP
nct id: NCT01683487
lead sponsor: 
has dmc: Yes
I. To investigate time measurement from emergency room admission to first antibiotic
      administration.

      II. To evaluate risk factors for prolonged time to first antibiotic administration.

      III. To correlate time measurement with Charlson comorbidity index and multimorbidity
      patterns.

      IV. To investigate the impact of a delayed time to first antibiotic administration on the
      outcome
In this retrospective cohort study, we plan to include all patients presenting with a
      community-acquired pneumococcal pneumonia at the University Hospital of Zurich between
      January 1, 2006 and June 30, 2012 (6½ years). The patients will be identified either with one
      or more blood culture pairs positive for S. pneumoniae or with a positive pneumococcal urine
      antigen assay in combination with the clinical diagnosis of CAP, which was based on the
      presence of select clinical features (e.g., cough, fever, sputum production, and pleuritic
      chest pain) and is supported by imaging of the lung, usually by chest radiography according
      to Infectious Diseases Society of America/American Thoracic Society consensus guidelines on
      the management of CAP in adults [11].

      CAP is not considered if the patient is discharged from a hospital less than 7 days before
      the current hospital admission, if the first blood culture or urinary antigen assay is
      obtained more than 1 week after hospital admission, or if the patient has no clinical
      diagnosis of CAP at the time of admission. Patients referred from or transferred to another
      hospital are excluded.

      After identification of eligible patients upon microbiological results, medical records are
      reviewed using a standardized data collection questionnaire. Comorbidity is determined using
      the Charlson comorbidity index [10]. Additionally, all patients are classified according to
      the multimorbidity patterns proposed by Holden et al. [12]. These are:

        1. arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;

        2. asthma, chronic obstructive pulmonary disease, and allergies;

        3. back/neck pain, migraine, other chronic pain, and arthritis;

        4. high blood pressure, high cholesterol, obesity, diabetes, and fatigue;

        5. cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and
           arthritis; and

        6. irritable bowel, ulcer, heartburn, and other chronic pain.

      Time calculation is based upon the moment of emergency room (ER) admission.
observational model: Case-Only
time perspective: Retrospective
measure: In-hospital mortaliy
time frame: From day of admission until discharge or dead
description: Mortality during hospitalization because of pneumococcal pneumonia
intervention type: Procedure
intervention name: Observation
description: Observational study only, no intervention.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Franzen, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Internal Medicine
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Pneumococcal