Hospital-acquired PneumoniaNCT04403971
0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia
A study testing 0.12% Chlorhexidine Oral Liquid Product, Listerine Oral Liquid Product and Normal Saline Product in people with Hospital-acquired Pneumonia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hospital-acquired Pneumonia
- What is being tested?
- 0.12% Chlorhexidine Oral Liquid Product, Listerine Oral Liquid Product and Normal Saline Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients > 20 years old without ventilator
Who cannot join
- known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients
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.
Read the 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.
- Conditions
- Hospital-acquired Pneumonia
- Being tested
- 0.12% Chlorhexidine Oral Liquid Product, Listerine Oral Liquid Product, Normal Saline Product
- Keywords
- 0.12% chlorhexidine, Oral rinse, Hospital-acquired pneumonia
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% Chlorhexidine Oral Liquid ProductDrug
The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
Listerine Oral Liquid ProductDrug
The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
Normal Saline ProductOther
The control group received 10ml normal saline for oral rinse twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 0.12% chlorhexidine | Experimental | Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers. Receives: 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. Receives: Drug: Listerine Oral Liquid Product |
| Normal saline | Placebo comparator | Participants will be randomized to Normal saline group, applied twice a day by care givers. Receives: Other: Normal Saline Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral bacterial colonization status
Measured: 1 year
Secondary outcomes (1)
The rate of non-ventilator associated pneumonia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start25 May 2020
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen, Yen-Chin, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403971
- Sponsor's protocol ID
- A-ER-108-309
- Status last verified
- Dec 2021
- First submitted
- 21 May 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30814830Giuliano 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.
PubMed 29050905Quinn 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.
PubMed 24119253Chou 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.
PubMed 30612923Zhang 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.
PubMed 29405627
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04403971
- Acronym / sponsor ID
- A-ER-108-309
- Conditions
- Hospital-acquired Pneumonia
- Keywords
- 0.12% chlorhexidine, Oral rinse, Hospital-acquired pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.12% chlorhexidine | Experimental | Drug: 0.12% Chlorhexidine Oral Liquid ProductParticipants will be randomized to Chlorhexidine solution group, applied twice a day by care givers. |
| Listerine | Sham comparator | Drug: Listerine Oral Liquid ProductParticipants will be randomized to Listerine solution group, applied twice a day by care givers. |
| Normal saline | Placebo comparator | Other: Normal Saline ProductParticipants will be randomized to Normal saline group, applied twice a day by care givers. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients > 20 years old without ventilator
Key exclusion criteria (1 listed)
- known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.12% Chlorhexidine Oral Liquid ProductThe intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day. | Drug | 0.12% chlorhexidine |
| Listerine Oral Liquid ProductThe intervention group 2 received 10ml Listerine solution for oral rinse twice a day. | Drug | Listerine |
| Normal Saline ProductThe control group received 10ml normal saline for oral rinse twice a day. | Other | Normal saline |
Primary outcome
oral bacterial colonization status
Time frame: 1 year
1 secondary outcome
The rate of non-ventilator associated pneumonia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Background: PubMed 30814830Sangmuang 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.
- Background: PubMed 29050905Giuliano 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.
- Background: PubMed 24119253Quinn 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.
- Background: PubMed 30612923Chou 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.
- Background: PubMed 29405627Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.12% Chlorhexidine Oral Liquid Product, Listerine Oral Liquid Product and Normal Saline Product in people with Hospital-acquired Pneumonia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral bacterial colonization status (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403971, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.