PneumoniaPhase 2NCT00123123
Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients
A Phase 2 study testing chlorhexidine gluconate oral rinse (0.12%) in people with Pneumonia, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- chlorhexidine gluconate oral rinse (0.12%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Nov 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 included in this study will be those admitted to the trauma intensive care unit (TICU) of Erie County Medical Center (ECMC) hospital. All patients admitted to the TICU who are intubated and mechanically ventilated within 24-48 hours of admission will be eligible for study admission, with the exception of those demonstrating the following exclusion criteria: a) a witnessed aspiration (to eliminate patients with chemical pneumonitis); b) a confirmed diagnosis of post-obstructive pneumonia (e.g. advanced lung cancer); c) a known hypersensitivity to CHX; d) patients for whom consent can not be obtained; e) a diagnosed thrombocytopenia (platelet count less than 40 and/or a INR above 2) or other coagulopathy; f) a do not intubate order; g) children under the age of 18 years; h) Pregnant women; i) Legal incarceration; j) If transferred from another ICU; k) Those with oral mucositis; l) Those with immunosuppression (either-HIV or drug induced [e.g. organ transplant patients or those on long term steroid therapy]); m) Patients re-admitted to the TICU
- Comatose and intubated patients will be included since they represent patients at greatest risk for respiratory infection.
Who cannot join
- Patients for whom consent can not be obtained.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Buffalo, The State University of New York
Buffalo, New York, 14214
About this study
Official title: Oral Health and Ventilator-associated Pneumonia
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).
The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.
Read the detailed description
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The Specific Aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients. This pilot longitudinal, double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients. Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large-scale multi-center clinical trial; and 3) to perform molecular epidemiological studies to identify and genetically type bacteria cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to isolates of the same species from their dental plaque.
This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure, patient recruitment and methodologic protocols, and data management and analysis procedures necessary to perform a multi-center, controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP.
- Conditions
- Pneumonia
- Being tested
- chlorhexidine gluconate oral rinse (0.12%), placebo
- Keywords
- Ventilator-associated pneumonia
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine gluconate oral rinse (0.12%)Drug
chlorhexidine gluconate oral rinse
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Vehicle Control) | Placebo comparator | Delivered Twice a day Receives: Drug: placebo |
| 0.12% chlorhexidine gluconate oral rinse | Experimental | Delivered twice a day Receives: Drug: chlorhexidine gluconate oral rinse (0.12%) |
| 0.12% chlorhexidine oral rinse | Experimental | Delivered once a day, placebo once a day Receives: Drug: chlorhexidine gluconate oral rinse (0.12%); Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours
Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.
Measured: Every 48 hours until discharge
Secondary outcomes (1)
Clinical Pulmonary Infection Score (CPIS) at 48 Hours
The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate:
0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startMar 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Frank Scannapieco, State University of New York at Buffalo
- Investigators
- Frank A. Scannapieco, DMD PhD, Study chair, University at Buffalo, The State University of New YorkFrank A. Scannapieco, DMD PhD, Principal investigator, The State University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123123
- Sponsor's protocol ID
- NIDCR-14685
- Other IDs
- R01DE014685, 1R01-DE-14685-1A2
- Status last verified
- Aug 2010
- First submitted
- 21 Jul 2005
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Scannapieco FA, Yu J, Raghavendran K, Vacanti A, Owens SI, Wood K, Mylotte JM. A randomized trial of chlorhexidine gluconate on oral bacterial pathogens in mechanically ventilated patients. Crit Care. 2009;13(4):R117. doi: 10.1186/cc7967. Epub 2009 Jul 15.
PubMed 19765321Heo SM, Haase EM, Lesse AJ, Gill SR, Scannapieco FA. Genetic relationships between respiratory pathogens isolated from dental plaque and bronchoalveolar lavage fluid from patients in the intensive care unit undergoing mechanical ventilation. Clin Infect Dis. 2008 Dec 15;47(12):1562-70. doi: 10.1086/593193.
PubMed 18991508
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health and Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT00123123
- Acronym / sponsor ID
- NIDCR-14685
- Conditions
- Pneumonia
- Keywords
- Ventilator-associated pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Mar 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Posted 9 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).
The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.
Detailed description
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The Specific Aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients. This pilot longitudinal, double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients. Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large-scale multi-center clinical trial; and 3) to perform molecular epidemiological studies to identify and genetically type bacteria cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to isolates of the same species from their dental plaque.
This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure, patient recruitment and methodologic protocols, and data management and analysis procedures necessary to perform a multi-center, controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (Vehicle Control) | Placebo comparator | Drug: placeboDelivered Twice a day |
| 0.12% chlorhexidine gluconate oral rinse | Experimental | Drug: chlorhexidine gluconate oral rinse (0.12%)Delivered twice a day |
| 0.12% chlorhexidine oral rinse | Experimental | Drug: chlorhexidine gluconate oral rinse (0.12%), Drug: placeboDelivered once a day, placebo once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients included in this study will be those admitted to the trauma intensive care unit (TICU) of Erie County Medical Center (ECMC) hospital. All patients admitted to the TICU who are intubated and mechanically ventilated within 24-48 hours of admission will be eligible for study admission, with the exception of those demonstrating the following exclusion criteria: a) a witnessed aspiration (to eliminate patients with chemical pneumonitis); b) a confirmed diagnosis of post-obstructive pneumonia (e.g. advanced lung cancer); c) a known hypersensitivity to CHX; d) patients for whom consent can not be obtained; e) a diagnosed thrombocytopenia (platelet count less than 40 and/or a INR above 2) or other coagulopathy; f) a do not intubate order; g) children under the age of 18 years; h) Pregnant women; i) Legal incarceration; j) If transferred from another ICU; k) Those with oral mucositis; l) Those with immunosuppression (either-HIV or drug induced [e.g. organ transplant patients or those on long term steroid therapy]); m) Patients re-admitted to the TICU
- Comatose and intubated patients will be included since they represent patients at greatest risk for respiratory infection.
Key exclusion criteria (1 listed)
- Patients for whom consent can not be obtained.
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 |
|---|---|---|
| chlorhexidine gluconate oral rinse (0.12%)chlorhexidine gluconate oral rinse | Drug | 0.12% chlorhexidine gluconate oral rinse, 0.12% chlorhexidine oral rinse |
| placebo | Drug | 0.12% chlorhexidine oral rinse, Placebo (Vehicle Control) |
Primary outcome
Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours
Time frame: Every 48 hours until discharge
Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.
1 secondary outcome
Clinical Pulmonary Infection Score (CPIS) at 48 Hours
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19765321Scannapieco FA, Yu J, Raghavendran K, Vacanti A, Owens SI, Wood K, Mylotte JM. A randomized trial of chlorhexidine gluconate on oral bacterial pathogens in mechanically ventilated patients. Crit Care. 2009;13(4):R117. doi: 10.1186/cc7967. Epub 2009 Jul 15.
- Results publication: PubMed 18991508Heo SM, Haase EM, Lesse AJ, Gill SR, Scannapieco FA. Genetic relationships between respiratory pathogens isolated from dental plaque and bronchoalveolar lavage fluid from patients in the intensive care unit undergoing mechanical ventilation. Clin Infect Dis. 2008 Dec 15;47(12):1562-70. doi: 10.1086/593193.
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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.
Frank A. Scannapieco, DMD PhD study chair
University at Buffalo, The State University of New York
Frank A. Scannapieco, DMD PhD principal investigator
The State University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chlorhexidine gluconate oral rinse (0.12%) in people with Pneumonia, run by State University of New York at Buffalo at 1 site in United States.
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 2 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 5 May 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours (time frame: Every 48 hours until discharge). 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 NCT00123123, 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 5 May 2021.