<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/NCT01660204</url>
  </required_header>
  <id_info>
    <org_study_id>10-148</org_study_id>
    <secondary_id>80-82310-97-12044</secondary_id>
    <nct_id>NCT01660204</nct_id>
  </id_info>
  <brief_title>Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections</brief_title>
  <acronym>CAP-START</acronym>
  <official_title>Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic&#xD;
      strategies for patients with community-acquired pneumonia admitted to the hospital, but not&#xD;
      the ICU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Day 90 Mortality</measure>
    <time_frame>90 days from admission</time_frame>
    <description>We will assess all-cause mortality on day 90 from admission from the municipal personal records database</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of intravenous antibiotic treatment</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week</time_frame>
    <description>Side-effects and complications from antibiotic therapy are registered from clinical record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week</time_frame>
    <description>Complications of pneumonia during admission are registered from clinical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care costs and non-health care costs</measure>
    <time_frame>28 days from admission</time_frame>
    <description>Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2283</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Betalactam monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Betalactam combination with macrolide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quinolone monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preferred empirical treatment</intervention_name>
    <description>The investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences.</description>
    <arm_group_label>Betalactam combination with macrolide</arm_group_label>
    <arm_group_label>Betalactam monotherapy</arm_group_label>
    <arm_group_label>Quinolone monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to one of the participating hospitals needing treatment for CAP,&#xD;
             not being admitted to the ICU are eligible for study inclusion.&#xD;
&#xD;
          -  Admission is defined as hospital stay for more than 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are readmitted with CAP within 2 weeks after a previous episode are not&#xD;
             eligible.&#xD;
&#xD;
          -  Patients with cystic fibrosis are not eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc J. Bonten, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Center Alkmaar</name>
      <address>
        <city>Alkmaar</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMC Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital Breda</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennemer Gasthuis</name>
      <address>
        <city>Haarlem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaarne Hospital</name>
      <address>
        <city>Hoofddorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonessenhuis Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>May 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>April 22, 2014</last_update_submitted>
  <last_update_submitted_qc>April 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>MJM Bonten</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pneumonia, anti-bacterial agents, (cost)efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT01660204
org study id: 10-148
secondary id: 80-82310-97-12044
nct id: NCT01660204
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic
      strategies for patients with community-acquired pneumonia admitted to the hospital, but not
      the ICU.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Day 90 Mortality
time frame: 90 days from admission
description: We will assess all-cause mortality on day 90 from admission from the municipal personal records database
measure: Length of intravenous antibiotic treatment
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Length of hospital stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Tolerability
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
description: Side-effects and complications from antibiotic therapy are registered from clinical record
measure: Complications
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
description: Complications of pneumonia during admission are registered from clinical record.
measure: Health care costs and non-health care costs
time frame: 28 days from admission
description: Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission
arm group label: Betalactam monotherapy
arm group type: Active Comparator
description: Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone
arm group label: Betalactam combination with macrolide
arm group type: Active Comparator
description: Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin
arm group label: Quinolone monotherapy
arm group type: Active Comparator
description: Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin
intervention type: Other
intervention name: Preferred empirical treatment
description: The investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences.
arm group label: Betalactam combination with macrolide
arm group label: Betalactam monotherapy
arm group label: Quinolone monotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc J. Bonten, MD PhD
role: Principal Investigator
affiliation: UMC Utrecht
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: MJM Bonten
investigator title: Professor
mesh term: Pneumonia