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Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00123123 |
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.
Condition | Intervention | Phase |
---|---|---|
Pneumonia |
Drug: chlorhexidine gluconate oral rinse (0.12%) |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Oral Health and Ventilator-Associated Pneumonia |
Estimated Enrollment: | 250 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Buffalo, The State University of New York | |
Buffalo, New York, United States, 14214 |
Study Chair: | Frank A. Scannapieco, DMD PhD | University at Buffalo, The State University of New York |
Principal Investigator: | Frank A. Scannapieco, DMD PhD | The State University of New York |
Responsible Party: | University of Buffalo ( Frank A Scannapieco, DMD, Ph.D ) |
Study ID Numbers: | NIDCR-14685, 1R01-DE-14685-1A2 |
Study First Received: | July 21, 2005 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00123123 |
Health Authority: | United States: Federal Government |
Ventilator-associated pneumonia |
Chlorhexidine Respiratory Tract Infections Respiratory Tract Diseases Chlorhexidine gluconate |
Lung Diseases Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
Anti-Infective Agents Anti-Infective Agents, Local Disinfectants Therapeutic Uses |
Infection Dermatologic Agents Pharmacologic Actions |