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Clinical Trials/NCT04403971
NCT04403971
Completed
Not Applicable

Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients

National Cheng-Kung University Hospital1 site in 1 country103 target enrollmentStarted: May 25, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
103
Locations
1
Primary Endpoint
oral bacterial colonization status

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 100 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

0.12% chlorhexidine

Experimental

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

Intervention: 0.12% Chlorhexidine Oral Liquid Product (Drug)

Listerine

Sham Comparator

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

Intervention: Listerine Oral Liquid Product (Drug)

Normal saline

Placebo Comparator

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

Intervention: Normal Saline Product (Other)

Outcomes

Primary Outcomes

oral bacterial colonization status

Time Frame: 1 year

Secondary Outcomes

  • The rate of non-ventilator associated pneumonia(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chen, Yen-Chin

Vice Head Nurse and Clinical Assistant Professor

National Cheng-Kung University Hospital

Study Sites (1)

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