<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/NCT03290105</url>
  </required_header>
  <id_info>
    <org_study_id>HLM_JDR7</org_study_id>
    <nct_id>NCT03290105</nct_id>
  </id_info>
  <brief_title>Microbial and Pharmacological Assessment of Chlorhexidine</brief_title>
  <official_title>Efficacy of Chlorhexidine Mouth Wash in ICU Ventilated Patients: Microbiological Effects and Antiseptic Residual Concentrations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Louis Mourier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Louis Mourier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial&#xD;
      infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step&#xD;
      toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most&#xD;
      widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy&#xD;
      on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial&#xD;
      efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in&#xD;
      patients' saliva at the same time-points after CMW.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ventilator associated pneumonia (VAP) is the most frequent life-threatening nosocomial&#xD;
      infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step&#xD;
      toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most&#xD;
      widespread preventive measure to prevent VAP. Although many guidelines and expert opinions&#xD;
      recommend oral hygiene with chlorhexidine, optimal conditions of CMW use remain unknown. In&#xD;
      addition, precise microbial documentation of CMW efficacy on oropharyngeal colonization is&#xD;
      lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated&#xD;
      patients and to measure chlorhexidine residual concentration in the saliva at the same&#xD;
      time-points after CMW.&#xD;
&#xD;
      In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine&#xD;
      solution.&#xD;
&#xD;
      Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just&#xD;
      before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2&#xD;
      hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial&#xD;
      growth.&#xD;
&#xD;
      In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time&#xD;
      points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2014</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2014</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>changes over time of bacterial growth</measure>
    <time_frame>6 hours (360 minutes)</time_frame>
    <description>oropharyngeal colonization (i.e., amount of bacterial growth in each oropharyngeal sample) before and after a mouth wash with chlorhexidine will be measured at different time points (before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes over time of bacterial growth of each bacterial specie</measure>
    <time_frame>6 hours (360 minutes)</time_frame>
    <description>changes over time in bacterial growth of each bacterial species isolated in the oropharynx will be measured before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>susceptibility of isolates to chlorhexidine</measure>
    <time_frame>1 hour</time_frame>
    <description>chlorhexidine minimal inhibitory concentration of dominant pathogens of each patient will be determined using the broth microdilution method recommended by the Clinical &amp; Laboratory Standards Institute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary concentration of chlorhexidine</measure>
    <time_frame>6 hours (360 minutes)</time_frame>
    <description>salivary concentration of chlorhexidine will be measured 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine using high-pressure liquid chromatography</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Oropharynx Abnormality</condition>
  <condition>Pneumonia, Ventilator-Associated</condition>
  <condition>Chlorhexidine</condition>
  <condition>Bacterium; Agent</condition>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>study population</arm_group_label>
    <description>Consecutive critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      saliva for measurement of chlorhexidine concentration; swabbing of oropharyngeal secretions&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        - Consecutive critically-ill patients admitted to the ICU and receiving invasive mechanical&#xD;
        ventilation for more than 48 hours&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  critically-ill patients admitted to the ICU and receiving invasive mechanical&#xD;
             ventilation for more than 48 hours&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
          -  cervical or mouth surgery in the last 15 days;&#xD;
&#xD;
          -  history of oropharyngeal neoplasm or of cervical or oropharyngeal radiotherapy,&#xD;
&#xD;
          -  tracheotomy,&#xD;
&#xD;
          -  age under 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose samples retrieved less than 10 to the 3 colony forming unit (CFU)/mL&#xD;
             bacteria and those who had two or more missing microbiological samples were&#xD;
             secondarily excluded&#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>Jean-Damien Ricard, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Béatrice La Combe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <reference>
    <citation>Klompas M. Oropharyngeal Decontamination with Antiseptics to Prevent Ventilator-Associated Pneumonia: Rethinking the Benefits of Chlorhexidine. Semin Respir Crit Care Med. 2017 Jun;38(3):381-390. doi: 10.1055/s-0037-1602584. Epub 2017 Jun 4.</citation>
    <PMID>28578560</PMID>
  </reference>
  <reference>
    <citation>Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359.</citation>
    <PMID>24663255</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Louis Mourier</investigator_affiliation>
    <investigator_full_name>Prof Jean-Damien RICARD</investigator_full_name>
    <investigator_title>Professor of Intensive Care</investigator_title>
  </responsible_party>
  <keyword>oropharyngeal colonization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03290105
org study id: HLM_JDR7
nct id: NCT03290105
lead sponsor: 
has dmc: No
is us export: No
Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial
      infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step
      toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most
      widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy
      on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial
      efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in
      patients' saliva at the same time-points after CMW.
Ventilator associated pneumonia (VAP) is the most frequent life-threatening nosocomial
      infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step
      toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most
      widespread preventive measure to prevent VAP. Although many guidelines and expert opinions
      recommend oral hygiene with chlorhexidine, optimal conditions of CMW use remain unknown. In
      addition, precise microbial documentation of CMW efficacy on oropharyngeal colonization is
      lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated
      patients and to measure chlorhexidine residual concentration in the saliva at the same
      time-points after CMW.

      In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine
      solution.

      Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just
      before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2
      hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial
      growth.

      In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time
      points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.
observational model: Cohort
time perspective: Prospective
measure: changes over time of bacterial growth
time frame: 6 hours (360 minutes)
description: oropharyngeal colonization (i.e., amount of bacterial growth in each oropharyngeal sample) before and after a mouth wash with chlorhexidine will be measured at different time points (before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine)
measure: changes over time of bacterial growth of each bacterial specie
time frame: 6 hours (360 minutes)
description: changes over time in bacterial growth of each bacterial species isolated in the oropharynx will be measured before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine
measure: susceptibility of isolates to chlorhexidine
time frame: 1 hour
description: chlorhexidine minimal inhibitory concentration of dominant pathogens of each patient will be determined using the broth microdilution method recommended by the Clinical & Laboratory Standards Institute
measure: salivary concentration of chlorhexidine
time frame: 6 hours (360 minutes)
description: salivary concentration of chlorhexidine will be measured 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine using high-pressure liquid chromatography
arm group label: study population
description: Consecutive critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours
saliva for measurement of chlorhexidine concentration; swabbing of oropharyngeal secretions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Damien Ricard, MD, PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Béatrice La Combe, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
citation: Klompas M. Oropharyngeal Decontamination with Antiseptics to Prevent Ventilator-Associated Pneumonia: Rethinking the Benefits of Chlorhexidine. Semin Respir Crit Care Med. 2017 Jun;38(3):381-390. doi: 10.1055/s-0037-1602584. Epub 2017 Jun 4.
PMID: 28578560
citation: Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359.
PMID: 24663255
responsible party type: Principal Investigator
investigator affiliation: Hôpital Louis Mourier
investigator full name: Prof Jean-Damien RICARD
investigator title: Professor of Intensive Care
mesh term: Bacterial Infections
mesh term: Pneumonia, Ventilator-Associated
sharing ipd: Undecided