Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

NCT00123123 | Completed Phase 2 Results

• 3 other identifiers: NIDCR-14685R01DE0146851R01-DE-14685-1A2
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Pneumonia

Keywords

Ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 48 hours until discharge

Secondary Outcomes (1)

• Clinical Pulmonary Infection Score (CPIS) at 48 Hours

  48 hours

Study Arms (3)

Placebo (Vehicle Control)

PLACEBO COMPARATOR

Delivered Twice a day

Drug: placebo

0.12% chlorhexidine gluconate oral rinse

EXPERIMENTAL

Delivered twice a day

Drug: chlorhexidine gluconate oral rinse (0.12%)

0.12% chlorhexidine oral rinse

EXPERIMENTAL

Delivered once a day, placebo once a day

Drug: chlorhexidine gluconate oral rinse (0.12%); Drug: placebo

Interventions

chlorhexidine gluconate oral rinse (0.12%) DRUG

chlorhexidine gluconate oral rinse

0.12% chlorhexidine gluconate oral rinse; 0.12% chlorhexidine oral rinse

placebo DRUG

0.12% chlorhexidine oral rinse; Placebo (Vehicle Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Comatose and intubated patients will be included since they represent patients at greatest risk for respiratory infection.
• Patients for whom consent can not be obtained.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Buffalo, The State University of New York

Buffalo, New York, 14214, United States

Location

Related Publications (2)

• 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.

  PMID: 19765321 RESULT

• Heo 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.

  PMID: 18991508 RESULT

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Frank A. Scannapieco
• Organization: University at Buffalo

fas1@buffalo.edu

716-829-3373

Study Officials

• Frank A. Scannapieco, DMD PhD

  University at Buffalo, The State University of New York

  STUDY CHAIR

• Frank A. Scannapieco, DMD PhD

  The State University of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: March 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 5, 2021
• Results First Posted: September 9, 2010

Record last verified: 2010-08

Locations

US (1)