0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia

NCT ID: NCT04403971

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Hospital-acquired Pneumonia

Keywords

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0.12% chlorhexidine Oral rinse Hospital-acquired pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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0.12% chlorhexidine

Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers.

Group Type EXPERIMENTAL

0.12% Chlorhexidine Oral Liquid Product

Intervention Type DRUG

The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.

Listerine

Participants will be randomized to Listerine solution group, applied twice a day by care givers.

Group Type SHAM_COMPARATOR

Listerine Oral Liquid Product

Intervention Type DRUG

The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.

Normal saline

Participants will be randomized to Normal saline group, applied twice a day by care givers.

Group Type PLACEBO_COMPARATOR

Normal Saline Product

Intervention Type OTHER

The control group received 10ml normal saline for oral rinse twice a day.

Interventions

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0.12% Chlorhexidine Oral Liquid Product

The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.

Intervention Type DRUG

Listerine Oral Liquid Product

The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.

Intervention Type DRUG

Normal Saline Product

The control group received 10ml normal saline for oral rinse twice a day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients \> 20 years old without ventilator

Exclusion Criteria

* known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen, Yen-Chin

Vice Head Nurse and Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yen-Chin Chen

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 30814830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29050905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24119253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30612923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29405627 (View on PubMed)

Other Identifiers

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A-ER-108-309

Identifier Type: -

Identifier Source: org_study_id