Nosocomial PneumoniaNCT06691399
Role of Oral Care in Prevention of Nosocomial Pneumonia Among COPD Patients
A study testing Oral care in people with Nosocomial Pneumonia and COPD Exacerbation, run by Assiut University at 1 site in Egypt.
Trial summary
Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Pneumonia, COPD Exacerbation
- What is being tested?
- Oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as COPD
- admitted to ICU with acute exacerbation
- need for noninvasive ventilatory support including noninvasive ventilation anf high flow nasal cannula
Who cannot join
- patients refusing to participate
- End stage organ failure (Heart Failure, Liver cell failure and/or Renal failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Assiut University
Asyut, 711111
waleed MD Gamal Elddin Khaleel, Ass. Prof., +201006519722, waleed_gamal@aun.edu.eg
Maiada MD Kamaleldin Hashem, Ass. Prof., +201006559662, Maiada.hashem@aun.edu.eg
About this study
Official title: Routine Oral Care Versus Chlorhexidine Oral Care on Incidence of Nosocomial Pneumonia and Oral Health Among Critically Ill Non-intubated Patients With COPD
Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.
Read the detailed description
Infection is a common problem and a major cause of morbidity and mortality for patients in intensive care units (ICUs). Pneumonia is the most common site of infection according to an international study of the prevalence and outcomes of infection in ICUs, which included 13,796 patients. Nosocomial pneumonia (NP) is among the leading causes of mortality in patients in the ICU. Notably, the incidence of nosocomial pneumonia is increasing, and the number of infection-related deaths that follow is also increasing. Thus, preventing nosocomial pneumonia is a cost reducing and life-saving health care practice, especial in ICUs.
Nosocomial pneumonia (NP) was defined as an infection of the lower respiratory tract that does not exist at the time of admission and does not have an incubation period of infection but occurs 48 hours after admission. The most important cause for the development of nosocomial pneumonia is the oral environment. The oral cavity of ICU patients is an important reservoir for bacteria and provides a habitat for microorganisms that can lead to nosocomial pneumonia. Patients in ICUs acquire pneumonia by aspirating oral bacteria that have been colonized in the oral cavity into the lower respiratory tract. Due to advanced age, limited mobility, illness, and cognitive dysfunction, patients in ICUs often have difficulty maintaining oral hygiene by themselves.
Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia. The aim of the present study is to assess value of preventive strategy using chlorhexidine for oral care among non-intubated COPD patients admitted to ICU upon incidence of nosocomial pneumonia.
- Conditions
- Nosocomial Pneumonia, COPD Exacerbation
- Being tested
- Oral care
- Keywords
- COPD, Oral care, Nosocomial pneumonia, Chlorhexidine
- Medical subject headings
- Healthcare-Associated Pneumonia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral careOther
Oral care done twice daily with chlorhexidine oral care solution (concentration 1.2%)
| Study group | Role | What they receive |
|---|---|---|
| Routine oral care (Group 1) | Placebo comparator | Group (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing Receives: Other: Oral care |
| Chlorhexidine oral care | Active comparator | Group (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing plus oral care with chlorohexidine solution (concentration 1.2%) Receives: Other: Oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nosocomial pneumonia
Incidence of nosocomial pneumonia diagnosed via clinical features and confirmed with either chest ultrasonography or chest radiography
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nosocomial PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed MD Gamal Elddin Khaleel, Ass. Prof., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691399
- Sponsor's protocol ID
- SOD2024
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
PubMed 19952319Vilela MC, Ferreira GZ, Santos PS, Rezende NP. Oral care and nosocomial pneumonia: a systematic review. Einstein (Sao Paulo). 2015 Apr-Jun;13(2):290-6. doi: 10.1590/S1679-45082015RW2980. Epub 2015 May 1.
PubMed 25946053
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Oral Care Versus Chlorhexidine Oral Care on Incidence of Nosocomial Pneumonia and Oral Health Among Critically Ill Non-intubated Patients With COPD
- ClinicalTrials.gov ID
- NCT06691399
- Acronym / sponsor ID
- SOD2024
- Conditions
- Nosocomial Pneumonia, COPD Exacerbation
- Keywords
- COPD, Oral care, Nosocomial pneumonia, Chlorhexidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Nov 2024 (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.
Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.
Detailed description
Infection is a common problem and a major cause of morbidity and mortality for patients in intensive care units (ICUs). Pneumonia is the most common site of infection according to an international study of the prevalence and outcomes of infection in ICUs, which included 13,796 patients. Nosocomial pneumonia (NP) is among the leading causes of mortality in patients in the ICU. Notably, the incidence of nosocomial pneumonia is increasing, and the number of infection-related deaths that follow is also increasing. Thus, preventing nosocomial pneumonia is a cost reducing and life-saving health care practice, especial in ICUs.
Nosocomial pneumonia (NP) was defined as an infection of the lower respiratory tract that does not exist at the time of admission and does not have an incubation period of infection but occurs 48 hours after admission. The most important cause for the development of nosocomial pneumonia is the oral environment. The oral cavity of ICU patients is an important reservoir for bacteria and provides a habitat for microorganisms that can lead to nosocomial pneumonia. Patients in ICUs acquire pneumonia by aspirating oral bacteria that have been colonized in the oral cavity into the lower respiratory tract. Due to advanced age, limited mobility, illness, and cognitive dysfunction, patients in ICUs often have difficulty maintaining oral hygiene by themselves.
Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia. The aim of the present study is to assess value of preventive strategy using chlorhexidine for oral care among non-intubated COPD patients admitted to ICU upon incidence of nosocomial pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine oral care (Group 1) | Placebo comparator | Other: Oral careGroup (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing |
| Chlorhexidine oral care | Active comparator | Other: Oral careGroup (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing plus oral care with chlorohexidine solution (concentration 1.2%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed as COPD
- admitted to ICU with acute exacerbation
- need for noninvasive ventilatory support including noninvasive ventilation anf high flow nasal cannula
Key exclusion criteria (2 listed)
- patients refusing to participate
- End stage organ failure (Heart Failure, Liver cell failure and/or Renal failure
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 |
|---|---|---|
| Oral careOral care done twice daily with chlorhexidine oral care solution (concentration 1.2%) | Other | Chlorhexidine oral care, Routine oral care (Group 1) |
Primary outcome
Incidence of nosocomial pneumonia
Time frame: 1 month
Incidence of nosocomial pneumonia diagnosed via clinical features and confirmed with either chest ultrasonography or chest radiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 19952319Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
- Background: PubMed 25946053Vilela MC, Ferreira GZ, Santos PS, Rezende NP. Oral care and nosocomial pneumonia: a systematic review. Einstein (Sao Paulo). 2015 Apr-Jun;13(2):290-6. doi: 10.1590/S1679-45082015RW2980. Epub 2015 May 1.
- 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.
Waleed MD Gamal Elddin Khaleel, Ass. Prof. principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral care in people with Nosocomial Pneumonia and COPD Exacerbation, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waleed MD Gamal Elddin Khaleel, Ass. Prof. (+201006519722, waleed_gamal@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nosocomial pneumonia (time frame: 1 month). 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 NCT06691399, which also lists 2 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 15 Nov 2024.