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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04403971
Other study ID # A-ER-108-309
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2020
Est. completion date December 31, 2020

Study information

Verified date December 2021
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria: - Hospitalized patients > 20 years old without ventilator Exclusion Criteria: - known hypersensitivity to or intolerance of Chlorhexidine or Listerine

Study Design


Intervention

Drug:
0.12% Chlorhexidine Oral Liquid Product
The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
Listerine Oral Liquid Product
The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
Other:
Normal Saline Product
The control group received 10ml normal saline for oral rinse twice a day.

Locations

Country Name City State
Taiwan Yen-Chin Chen Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary oral bacterial colonization status 1 year
Secondary The rate of non-ventilator associated pneumonia 1 year
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