<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/NCT04403971</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-108-309</org_study_id>
    <nct_id>NCT04403971</nct_id>
  </id_info>
  <brief_title>0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia</brief_title>
  <official_title>Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      Chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. However,&#xD;
      it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of&#xD;
      non-ventilator hospital-acquired pneumonia among hospitalized patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be classified into three groups, applied twice a day by care givers. Oral&#xD;
      colonization will be tested in the baseline, day-3, day-7, and at the discharge. Quantitation&#xD;
      of colonization of the oral cavity by oral rinses and respiratory pathogens were measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oral bacterial colonization status</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of non-ventilator associated pneumonia</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Hospital-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>0.12% chlorhexidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Listerine</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will be randomized to Listerine solution group, applied twice a day by care givers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomized to Normal saline group, applied twice a day by care givers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.12% Chlorhexidine Oral Liquid Product</intervention_name>
    <description>The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.</description>
    <arm_group_label>0.12% chlorhexidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Listerine Oral Liquid Product</intervention_name>
    <description>The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.</description>
    <arm_group_label>Listerine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline Product</intervention_name>
    <description>The control group received 10ml normal saline for oral rinse twice a day.</description>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients &gt; 20 years old without ventilator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known hypersensitivity to or intolerance of Chlorhexidine or Listerine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yen-Chin Chen</name>
      <address>
        <city>Tainan</city>
        <zip>722</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Sangmuang P, Lucksiri A, Katip W. Factors Associated with Mortality in Immunocompetent Patients with Hospital-acquired Pneumonia. J Glob Infect Dis. 2019 Jan-Mar;11(1):13-18. doi: 10.4103/jgid.jgid_33_18.</citation>
    <PMID>30814830</PMID>
  </reference>
  <reference>
    <citation>Giuliano KK, Baker D, Quinn B. The epidemiology of nonventilator hospital-acquired pneumonia in the United States. Am J Infect Control. 2018 Mar;46(3):322-327. doi: 10.1016/j.ajic.2017.09.005. Epub 2017 Oct 16.</citation>
    <PMID>29050905</PMID>
  </reference>
  <reference>
    <citation>Quinn B, Baker DL, Cohen S, Stewart JL, Lima CA, Parise C. Basic nursing care to prevent nonventilator hospital-acquired pneumonia. J Nurs Scholarsh. 2014 Jan;46(1):11-9. doi: 10.1111/jnu.12050. Epub 2013 Sep 30.</citation>
    <PMID>24119253</PMID>
  </reference>
  <reference>
    <citation>Chou CC, Shen CF, Chen SJ, Chen HM, Wang YC, Chang WS, Chang YT, Chen WY, Huang CY, Kuo CC, Li MC, Lin JF, Lin SP, Ting SW, Weng TC, Wu PS, Wu UI, Lin PC, Lee SS, Chen YS, Liu YC, Chuang YC, Yu CJ, Huang LM, Lin MC; Infectious Diseases Society of Taiwan;; Taiwan Society of Pulmonary and Critical Care Medicine,; Medical Foundation in Memory of Dr. Deh-Lin Cheng;; Foundation of Professor Wei-Chuan Hsieh for Infectious Diseases Research and Education;; CY Lee's Research Foundation for Pediatric Infectious Diseases and Vaccines,; 4th Guidelines Recommendations for Evidence-based Antimicrobial agents use in Taiwan (GREAT) working group. Recommendations and guidelines for the treatment of pneumonia in Taiwan. J Microbiol Immunol Infect. 2019 Feb;52(1):172-199. doi: 10.1016/j.jmii.2018.11.004. Epub 2018 Dec 6.</citation>
    <PMID>30612923</PMID>
  </reference>
  <reference>
    <citation>Zhang J, Ab Malik N, McGrath C, Lam O. The effect of antiseptic oral sprays on dental plaque and gingival inflammation: A systematic review and meta-analysis. Int J Dent Hyg. 2019 Feb;17(1):16-26. doi: 10.1111/idh.12331. Epub 2018 Feb 6.</citation>
    <PMID>29405627</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Chen, Yen-Chin</investigator_full_name>
    <investigator_title>Vice Head Nurse and Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>0.12% chlorhexidine</keyword>
  <keyword>Oral rinse</keyword>
  <keyword>Hospital-acquired pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Listerine</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/NCT04403971
org study id: A-ER-108-309
nct id: NCT04403971
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. However,
      it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of
      non-ventilator hospital-acquired pneumonia among hospitalized patients.
Participants will be classified into three groups, applied twice a day by care givers. Oral
      colonization will be tested in the baseline, day-3, day-7, and at the discharge. Quantitation
      of colonization of the oral cavity by oral rinses and respiratory pathogens were measured.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: oral bacterial colonization status
time frame: 1 year
measure: The rate of non-ventilator associated pneumonia
time frame: 1 year
arm group label: 0.12% chlorhexidine
arm group type: Experimental
description: Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers.
arm group label: Listerine
arm group type: Sham Comparator
description: Participants will be randomized to Listerine solution group, applied twice a day by care givers.
arm group label: Normal saline
arm group type: Placebo Comparator
description: Participants will be randomized to Normal saline group, applied twice a day by care givers.
intervention type: Drug
intervention name: 0.12% Chlorhexidine Oral Liquid Product
description: The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
arm group label: 0.12% chlorhexidine
intervention type: Drug
intervention name: Listerine Oral Liquid Product
description: The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
arm group label: Listerine
intervention type: Other
intervention name: Normal Saline Product
description: The control group received 10ml normal saline for oral rinse twice a day.
arm group label: Normal saline
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Taiwan
citation: Sangmuang P, Lucksiri A, Katip W. Factors Associated with Mortality in Immunocompetent Patients with Hospital-acquired Pneumonia. J Glob Infect Dis. 2019 Jan-Mar;11(1):13-18. doi: 10.4103/jgid.jgid_33_18.
PMID: 30814830
citation: Giuliano KK, Baker D, Quinn B. The epidemiology of nonventilator hospital-acquired pneumonia in the United States. Am J Infect Control. 2018 Mar;46(3):322-327. doi: 10.1016/j.ajic.2017.09.005. Epub 2017 Oct 16.
PMID: 29050905
citation: Quinn B, Baker DL, Cohen S, Stewart JL, Lima CA, Parise C. Basic nursing care to prevent nonventilator hospital-acquired pneumonia. J Nurs Scholarsh. 2014 Jan;46(1):11-9. doi: 10.1111/jnu.12050. Epub 2013 Sep 30.
PMID: 24119253
citation: Chou CC, Shen CF, Chen SJ, Chen HM, Wang YC, Chang WS, Chang YT, Chen WY, Huang CY, Kuo CC, Li MC, Lin JF, Lin SP, Ting SW, Weng TC, Wu PS, Wu UI, Lin PC, Lee SS, Chen YS, Liu YC, Chuang YC, Yu CJ, Huang LM, Lin MC; Infectious Diseases Society of Taiwan;; Taiwan Society of Pulmonary and Critical Care Medicine,; Medical Foundation in Memory of Dr. Deh-Lin Cheng;; Foundation of Professor Wei-Chuan Hsieh for Infectious Diseases Research and Education;; CY Lee's Research Foundation for Pediatric Infectious Diseases and Vaccines,; 4th Guidelines Recommendations for Evidence-based Antimicrobial agents use in Taiwan (GREAT) working group. Recommendations and guidelines for the treatment of pneumonia in Taiwan. J Microbiol Immunol Infect. 2019 Feb;52(1):172-199. doi: 10.1016/j.jmii.2018.11.004. Epub 2018 Dec 6.
PMID: 30612923
citation: Zhang J, Ab Malik N, McGrath C, Lam O. The effect of antiseptic oral sprays on dental plaque and gingival inflammation: A systematic review and meta-analysis. Int J Dent Hyg. 2019 Feb;17(1):16-26. doi: 10.1111/idh.12331. Epub 2018 Feb 6.
PMID: 29405627
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Chen, Yen-Chin
investigator title: Vice Head Nurse and Clinical Assistant Professor
mesh term: Pneumonia
mesh term: Healthcare-Associated Pneumonia
mesh term: Chlorhexidine
mesh term: Listerine
sharing ipd: No