<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/NCT03041207</url>
  </required_header>
  <id_info>
    <org_study_id>HM20009140</org_study_id>
    <nct_id>NCT03041207</nct_id>
  </id_info>
  <brief_title>Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection</brief_title>
  <acronym>VAIN2</acronym>
  <official_title>Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Gerber Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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 is a prospective study with three specific aims: (1) To convene a consensus conference&#xD;
      to develop a guideline for antibiotic use in infants (age &lt; 3 yrs) with suspected&#xD;
      ventilator-associated infection; (2) To evaluate outcomes before and after implementation of&#xD;
      the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course&#xD;
      of mechanical ventilation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2011 the Centers for Disease Control (CDC) estimated antibiotic-resistant infections&#xD;
      resulted in $20 billion in excess healthcare costs and more than 100,000 unnecessary deaths&#xD;
      in the U.S. alone. Ventilator-associated infections (VAI) are the most commonly diagnosed&#xD;
      hospital-acquired infections in the pediatric intensive care unit (PICU) and account for more&#xD;
      than half of all antibiotic use. We believe the diagnosis is often in error and that much of&#xD;
      the antibiotic use is unnecessary. Initiating broad-spectrum antibiotics is routine when VAI&#xD;
      or other infection is suspected in the child on mechanical ventilation, but our data show&#xD;
      when all other cultures are negative at 48-72 hours antibiotics are frequently still&#xD;
      continued based on identification of bacteria in respiratory secretion cultures. The&#xD;
      investigators have previously shown, however, that identification of bacteria in respiratory&#xD;
      secretion cultures is common in asymptomatic children and continuing antibiotics on the basis&#xD;
      of a &quot;positive&quot; respiratory secretion culture is not associated with a shorter hospital stay&#xD;
      or improved survival.&#xD;
&#xD;
      Antibiotics are not benign. Antibiotics are expensive, have disproportionate adverse effects&#xD;
      in younger children, often require placement of catheters that are themselves potential&#xD;
      sources of infection, and their overuse has been associated with increasing resistance&#xD;
      worldwide. Antibiotic exposure in young children has been associated with increased risk for&#xD;
      obesity, types 1 and 2 diabetes, inflammatory bowel diseases, celiac disease, allergies, and&#xD;
      asthma. Mouse studies have found that early antibiotic exposure disrupts the development of&#xD;
      the early-life gut bacterial composition (microbiome), leading to metabolic perturbations&#xD;
      that affect fat deposition and may alter normal immunologic development.&#xD;
&#xD;
      There is no diagnostic test for VAI and distinguishing tracheal bacterial colonization from&#xD;
      actual infection is not straightforward. The normal lung is essentially sterile but placement&#xD;
      of an endotracheal tube (ETT) compromises the lung's ability to clear aspirated secretions&#xD;
      and allows a direct route for bacterial contamination from the mouth and throat. The&#xD;
      resultant tracheal bacterial composition (the &quot;microbiome&quot;) is largely unstudied but&#xD;
      preliminary research suggests it consists of small numbers of a wide diversity of bacteria&#xD;
      originating from the mouth. Loss of this bacterial diversity in conjunction with&#xD;
      proliferation of pathological bacteria is thought to herald the conversion from colonization&#xD;
      to infection.&#xD;
&#xD;
      The investigators believe that a positive respiratory culture alone in the absence of other&#xD;
      indicators of infection is insufficient justification for continuing antibiotics and,&#xD;
      consequently, much of the antibiotic use in VAI is both unnecessary and potentially harmful.&#xD;
      To critically evaluate this belief and potentially decrease the use of unnecessary&#xD;
      antibiotics we propose the following:&#xD;
&#xD;
      Aim 1: To develop a guideline to assess the likelihood of VAI and discontinue antibiotics&#xD;
      when the risk is judged to be low Hypothesis 1.1: Using an iterative process PICU doctors can&#xD;
      reach consensus on criteria to assess the likelihood of VAI and discontinue antibiotics when&#xD;
      the risk of VAI is judged to be low&#xD;
&#xD;
      Aim 2: To assess the efficacy and safety of discontinuing antibiotics in children judged to&#xD;
      have a low risk of VAI Hypothesis 2.1: Discontinuing antibiotics at 48-72 hours in children&#xD;
      judged to have a low risk of VAI will result in fewer total days on antibiotics with no&#xD;
      difference in survival, numbers of subsequent infection episodes, duration of need for&#xD;
      mechanical ventilation and length of stay in the PICU compared to care prior to the&#xD;
      implementation of the guideline.&#xD;
&#xD;
      Aim 3: To describe the longitudinal changes in the tracheal bacterial composition (the&#xD;
      &quot;microbiome&quot;) in children on mechanical ventilation Hypothesis 3.1: Loss of diversity in the&#xD;
      tracheal microbiome will predate clinical signs and symptoms of VAI.&#xD;
&#xD;
      Hypothesis 3.2: Emergence of a dominant bacterial pathogen in the tracheal microbiome will be&#xD;
      associated with clinical signs and symptoms of VAI.&#xD;
&#xD;
      Decreasing unnecessary antibiotic use has important implications for public health. Pediatric&#xD;
      intensive care medicine is running out of effective antibiotics while also exposing our&#xD;
      children to antibiotic risks, many of which are only now beginning to be understood.&#xD;
      Avoidance of unnecessary antibiotic exposure in young children is critical and would be&#xD;
      facilitated by a rational guideline for assessment of the risk and appropriate treatment for&#xD;
      suspected VAI. As VAI is the most common reason for antibiotic use in the PICU, it is an&#xD;
      obvious target for more careful antibiotic stewardship. Better understanding of the normal&#xD;
      tracheal microbiome after placement of an endotracheal tube would also inform future&#xD;
      decisions regarding appropriate antibiotic use when VAI is suspected. The most effective&#xD;
      means of decreasing antibiotic resistance is avoidance of unnecessary use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric ICU-free days at 28 days</measure>
    <time_frame>28 days after study enrollment</time_frame>
    <description>28 - number of days in PICU (death = 0 free days)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibiotic days in PICU</measure>
    <time_frame>28 days after study enrollment</time_frame>
    <description>total number of antibiotic days with each antibiotic on each day = 1 antibiotic day (e.g., 3 antibiotics in one day = 3 antibiotic days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free days at 28 days</measure>
    <time_frame>28 days after study enrollment</time_frame>
    <description>28 - days on mechanical ventilation in PICU (death = 0 free days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection and sepsis episodes</measure>
    <time_frame>28 days after study enrollment</time_frame>
    <description>The number of infection and/or sepsis episodes after study enrollment</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">555</enrollment>
  <condition>Ventilator Associated Pneumonia</condition>
  <condition>Nosocomial Infections in Children</condition>
  <condition>Microbial Colonization</condition>
  <arm_group>
    <arm_group_label>Pre-antibiotic guideline</arm_group_label>
    <description>Infants for whom antibiotics have been initiated for suspected ventilator-associated infection prior to the implementation of the antibiotic guideline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>After antibiotic guideline implementation</arm_group_label>
    <description>Infants for whom antibiotics have been initiated for suspected ventilator-associated infection after the implementation of the antibiotic guideline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microbiome Study Group</arm_group_label>
    <description>Infants intubated and anticipated to require mechanical ventilation for at least several days</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Development and implementation of an antibiotic guideline</intervention_name>
    <description>A consensus conference will develop and then implement a guideline for stopping vs. continuing antibiotics in infants with suspected ventilator-associated infection</description>
    <arm_group_label>After antibiotic guideline implementation</arm_group_label>
    <arm_group_label>Pre-antibiotic guideline</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infants 0 - 3 years of age who have undergone a tracheal aspirate culture for suspected&#xD;
        ventilator-associated infection and have had antibiotics initiated at that time.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age newborn -- 3 years in the Pediatric ICU&#xD;
&#xD;
          -  on invasive mechanical ventilation &gt; 48 hours&#xD;
&#xD;
          -  evaluation for ventilator-associated infection that includes respiratory secretion&#xD;
             cultures and microscopic evaluation of the gram-stained specimen&#xD;
&#xD;
          -  antibiotics initiated for suspected ventilator-associated or other infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immune compromise --Other positive cultures (blood, urine, etc.) for which antibiotic&#xD;
             continuation is appropriate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas F Willson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Health System - Holtz Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta - Egleston Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children at Indiana University Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.S. Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital - Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Rainbow Babies &amp; Children's Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Children's Hospital</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Richmond at VCU</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier universitaire Sainte-Justine</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ventilator associated infection</keyword>
  <keyword>ventilator associated pneumonia</keyword>
  <keyword>ventilator associated tracheitis</keyword>
  <keyword>Lower respiratory infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_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/NCT03041207
org study id: HM20009140
nct id: NCT03041207
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective study with three specific aims: (1) To convene a consensus conference
      to develop a guideline for antibiotic use in infants (age < 3 yrs) with suspected
      ventilator-associated infection; (2) To evaluate outcomes before and after implementation of
      the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course
      of mechanical ventilation
In 2011 the Centers for Disease Control (CDC) estimated antibiotic-resistant infections
      resulted in $20 billion in excess healthcare costs and more than 100,000 unnecessary deaths
      in the U.S. alone. Ventilator-associated infections (VAI) are the most commonly diagnosed
      hospital-acquired infections in the pediatric intensive care unit (PICU) and account for more
      than half of all antibiotic use. We believe the diagnosis is often in error and that much of
      the antibiotic use is unnecessary. Initiating broad-spectrum antibiotics is routine when VAI
      or other infection is suspected in the child on mechanical ventilation, but our data show
      when all other cultures are negative at 48-72 hours antibiotics are frequently still
      continued based on identification of bacteria in respiratory secretion cultures. The
      investigators have previously shown, however, that identification of bacteria in respiratory
      secretion cultures is common in asymptomatic children and continuing antibiotics on the basis
      of a "positive" respiratory secretion culture is not associated with a shorter hospital stay
      or improved survival.

      Antibiotics are not benign. Antibiotics are expensive, have disproportionate adverse effects
      in younger children, often require placement of catheters that are themselves potential
      sources of infection, and their overuse has been associated with increasing resistance
      worldwide. Antibiotic exposure in young children has been associated with increased risk for
      obesity, types 1 and 2 diabetes, inflammatory bowel diseases, celiac disease, allergies, and
      asthma. Mouse studies have found that early antibiotic exposure disrupts the development of
      the early-life gut bacterial composition (microbiome), leading to metabolic perturbations
      that affect fat deposition and may alter normal immunologic development.

      There is no diagnostic test for VAI and distinguishing tracheal bacterial colonization from
      actual infection is not straightforward. The normal lung is essentially sterile but placement
      of an endotracheal tube (ETT) compromises the lung's ability to clear aspirated secretions
      and allows a direct route for bacterial contamination from the mouth and throat. The
      resultant tracheal bacterial composition (the "microbiome") is largely unstudied but
      preliminary research suggests it consists of small numbers of a wide diversity of bacteria
      originating from the mouth. Loss of this bacterial diversity in conjunction with
      proliferation of pathological bacteria is thought to herald the conversion from colonization
      to infection.

      The investigators believe that a positive respiratory culture alone in the absence of other
      indicators of infection is insufficient justification for continuing antibiotics and,
      consequently, much of the antibiotic use in VAI is both unnecessary and potentially harmful.
      To critically evaluate this belief and potentially decrease the use of unnecessary
      antibiotics we propose the following:

      Aim 1: To develop a guideline to assess the likelihood of VAI and discontinue antibiotics
      when the risk is judged to be low Hypothesis 1.1: Using an iterative process PICU doctors can
      reach consensus on criteria to assess the likelihood of VAI and discontinue antibiotics when
      the risk of VAI is judged to be low

      Aim 2: To assess the efficacy and safety of discontinuing antibiotics in children judged to
      have a low risk of VAI Hypothesis 2.1: Discontinuing antibiotics at 48-72 hours in children
      judged to have a low risk of VAI will result in fewer total days on antibiotics with no
      difference in survival, numbers of subsequent infection episodes, duration of need for
      mechanical ventilation and length of stay in the PICU compared to care prior to the
      implementation of the guideline.

      Aim 3: To describe the longitudinal changes in the tracheal bacterial composition (the
      "microbiome") in children on mechanical ventilation Hypothesis 3.1: Loss of diversity in the
      tracheal microbiome will predate clinical signs and symptoms of VAI.

      Hypothesis 3.2: Emergence of a dominant bacterial pathogen in the tracheal microbiome will be
      associated with clinical signs and symptoms of VAI.

      Decreasing unnecessary antibiotic use has important implications for public health. Pediatric
      intensive care medicine is running out of effective antibiotics while also exposing our
      children to antibiotic risks, many of which are only now beginning to be understood.
      Avoidance of unnecessary antibiotic exposure in young children is critical and would be
      facilitated by a rational guideline for assessment of the risk and appropriate treatment for
      suspected VAI. As VAI is the most common reason for antibiotic use in the PICU, it is an
      obvious target for more careful antibiotic stewardship. Better understanding of the normal
      tracheal microbiome after placement of an endotracheal tube would also inform future
      decisions regarding appropriate antibiotic use when VAI is suspected. The most effective
      means of decreasing antibiotic resistance is avoidance of unnecessary use.
observational model: Cohort
time perspective: Prospective
measure: Pediatric ICU-free days at 28 days
time frame: 28 days after study enrollment
description: 28 - number of days in PICU (death = 0 free days)
measure: Antibiotic days in PICU
time frame: 28 days after study enrollment
description: total number of antibiotic days with each antibiotic on each day = 1 antibiotic day (e.g., 3 antibiotics in one day = 3 antibiotic days)
measure: Ventilator-free days at 28 days
time frame: 28 days after study enrollment
description: 28 - days on mechanical ventilation in PICU (death = 0 free days)
measure: Infection and sepsis episodes
time frame: 28 days after study enrollment
description: The number of infection and/or sepsis episodes after study enrollment
arm group label: Pre-antibiotic guideline
description: Infants for whom antibiotics have been initiated for suspected ventilator-associated infection prior to the implementation of the antibiotic guideline
arm group label: After antibiotic guideline implementation
description: Infants for whom antibiotics have been initiated for suspected ventilator-associated infection after the implementation of the antibiotic guideline
arm group label: Microbiome Study Group
description: Infants intubated and anticipated to require mechanical ventilation for at least several days
intervention type: Behavioral
intervention name: Development and implementation of an antibiotic guideline
description: A consensus conference will develop and then implement a guideline for stopping vs. continuing antibiotics in infants with suspected ventilator-associated infection
arm group label: After antibiotic guideline implementation
arm group label: Pre-antibiotic guideline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Years
healthy volunteers: No
last name: Douglas F Willson, MD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
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facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
mesh term: Cross Infection
mesh term: Anti-Bacterial Agents
sharing ipd: No