0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia
Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04403971
Collaborator
(none)
103
1
3
7.2
14.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
103 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients
Actual Study Start Date
:
May 25, 2020
Actual Primary Completion Date
:
Oct 31, 2020
Actual Study Completion Date
:
Dec 31, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.12% chlorhexidine Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers. |
Drug: 0.12% Chlorhexidine Oral Liquid Product
The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
|
| Sham Comparator: Listerine Participants will be randomized to Listerine solution group, applied twice a day by care givers. |
Drug: Listerine Oral Liquid Product
The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
|
| Placebo Comparator: Normal saline Participants will be randomized to Normal saline group, applied twice a day by care givers. |
Other: Normal Saline Product
The control group received 10ml normal saline for oral rinse twice a day.
|
Outcome Measures
Primary Outcome Measures
- oral bacterial colonization status [1 year]
Secondary Outcome Measures
- The rate of non-ventilator associated pneumonia [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Hospitalized patients > 20 years old without ventilator
Exclusion Criteria:
- known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yen-Chin Chen | Tainan | Taiwan | 722 |
Sponsors and Collaborators
- National Cheng-Kung University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Chen, Yen-Chin,
Vice Head Nurse and Clinical Assistant Professor,
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT04403971
Other Study ID Numbers:
- A-ER-108-309
First Posted:
May 27, 2020
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chen, Yen-Chin,
Vice Head Nurse and Clinical Assistant Professor,
National Cheng-Kung University Hospital
Additional relevant MeSH terms: