Back to results0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia
Primary Purpose
Hospital-acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
0.12% Chlorhexidine Oral Liquid Product
Listerine Oral Liquid Product
Normal Saline Product
Sponsored by
About this trial
This is an interventional prevention trial for Hospital-acquired Pneumonia focused on measuring 0.12% chlorhexidine, Oral rinse, Hospital-acquired pneumonia
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients > 20 years old without ventilator
Exclusion Criteria:
- known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Sites / Locations
- Yen-Chin Chen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Placebo Comparator
Arm Label
0.12% chlorhexidine
Listerine
Normal saline
Arm Description
Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers.
Participants will be randomized to Listerine solution group, applied twice a day by care givers.
Participants will be randomized to Normal saline group, applied twice a day by care givers.
Outcomes
Primary Outcome Measures
oral bacterial colonization status
Secondary Outcome Measures
The rate of non-ventilator associated pneumonia
Full Information
NCT ID
NCT04403971
First Posted
May 21, 2020
Last Updated
December 13, 2021
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04403971
Brief Title
0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia
Official Title
Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-acquired Pneumonia
Keywords
0.12% chlorhexidine, Oral rinse, Hospital-acquired pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.12% chlorhexidine
Arm Type
Experimental
Arm Description
Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers.
Arm Title
Listerine
Arm Type
Sham Comparator
Arm Description
Participants will be randomized to Listerine solution group, applied twice a day by care givers.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to Normal saline group, applied twice a day by care givers.
Intervention Type
Drug
Intervention Name(s)
0.12% Chlorhexidine Oral Liquid Product
Intervention Description
The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
Intervention Type
Drug
Intervention Name(s)
Listerine Oral Liquid Product
Intervention Description
The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
Intervention Type
Other
Intervention Name(s)
Normal Saline Product
Intervention Description
The control group received 10ml normal saline for oral rinse twice a day.
Primary Outcome Measure Information:
Title
oral bacterial colonization status
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The rate of non-ventilator associated pneumonia
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients > 20 years old without ventilator
Exclusion Criteria:
known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Facility Information:
Facility Name
Yen-Chin Chen
City
Tainan
ZIP/Postal Code
722
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30814830
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.
Results Reference
background
PubMed Identifier
29050905
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.
Results Reference
background
PubMed Identifier
24119253
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.
Results Reference
background
PubMed Identifier
30612923
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.
Results Reference
background
PubMed Identifier
29405627
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.
Results Reference
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0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia
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