Clinical trial NCT04403971: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hospital-acquired Pneumonia
Keywords: 0.12% chlorhexidine
Oral rinse
Hospital-acquired pneumonia
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients \> 20 years old without ventilator

Exclusion Criteria:

* known hypersensitivity to or intolerance of Chlorhexidine or Listerine

Primary outcomes:
measure: oral bacterial colonization status
timeFrame: 1 year
Secondary outcomes:
measure: The rate of non-ventilator associated pneumonia
timeFrame: 1 year
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Yen-Chin Chen
Study officials:
References:
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: 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: 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: 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: 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.