NCT04403971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

May 21, 2020

Last Update Submit

December 13, 2021

Conditions

Hospital-acquired Pneumonia

Keywords

0.12% chlorhexidineOral rinseHospital-acquired pneumonia

Outcome Measures

Primary Outcomes (1)

  • oral bacterial colonization status

    1 year

Secondary Outcomes (1)

  • The rate of non-ventilator associated pneumonia

    1 year

Study Arms (3)

0.12% chlorhexidine

EXPERIMENTAL

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

Drug: 0.12% Chlorhexidine Oral Liquid Product

Listerine

SHAM COMPARATOR

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

Drug: Listerine Oral Liquid Product

Normal saline

PLACEBO COMPARATOR

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

Other: Normal Saline Product

Interventions

0.12% Chlorhexidine Oral Liquid ProductDRUG

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

0.12% chlorhexidine
Listerine Oral Liquid ProductDRUG

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

Listerine
Normal Saline ProductOTHER

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

Normal saline

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients \> 20 years old without ventilator

You may not qualify if:

  • known hypersensitivity to or intolerance of Chlorhexidine or Listerine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yen-Chin Chen

Tainan, 722, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 30814830BACKGROUND

  • 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.

    PMID: 29050905BACKGROUND

  • 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.

    PMID: 24119253BACKGROUND

  • 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.

    PMID: 30612923BACKGROUND

  • 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.

    PMID: 29405627BACKGROUND

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Head Nurse and Clinical Assistant Professor

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

May 25, 2020

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)