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Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00123123
First received: July 21, 2005
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition: Pneumonia
Interventions: Drug: chlorhexidine gluconate oral rinse (0.12%)
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 1 March, 2004 until 30 November, 2007. Subjects were recruited from patients admitted to the ICU of the Erie County Medical Center (ECMC) who were mechanically ventilated. This ICU provides trauma, burn care, and rehabilitation and is an affiliated teaching facility for the State University of New York at Buffalo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Vehicle control twice a day (oral rinse)
Chlorhexidine/Placebo Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
Chlorhexidine chlorhexidine 1 oz oral rinse twice a day

Participant Flow:   Overall Study
    Placebo     Chlorhexidine/Placebo     Chlorhexidine  
STARTED     59     58     58  
COMPLETED     59     58     58  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Vehicle control twice a day (oral rinse)
Chlorhexidine/Placebo Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
Chlorhexidine chlorhexidine 1 oz oral rinse twice a day
Total Total of all reporting groups

Baseline Measures
    Placebo     Chlorhexidine/Placebo     Chlorhexidine     Total  
Number of Participants  
[units: participants]
 		  59     58     58     175  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     59     58     58     175  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  50.0  ± 22.5     44.8  ± 19.9     47.6  ± 19.1     48.0  ± 20.8  
Gender  
[units: participants]
 		       
Female     23     15     14     52  
Male     36     43     44     123  
Region of Enrollment  
[units: participants]
 		       
United States     59     58     58     175  



  Outcome Measures
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1.  Primary:   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 ]

Measure Type Primary
Measure Title 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
Measure Description 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.
Time Frame Every 48 hours until discharge  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.

Reporting Groups
  Description
Placebo Vehicle control twice a day (oral rinse)
Chlorhexidine/Placebo Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
Chlorhexidine chlorhexidine 1 oz oral rinse twice a day

Measured Values
    Placebo     Chlorhexidine/Placebo     Chlorhexidine  
Number of Participants Analyzed  
[units: participants]
 		  59     58     58  
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  
[units: CFU/mL]
Mean ± Standard Deviation 		  7  ± 2     7.1  ± 1.9     5.1  ± 2  


Statistical Analysis 1 for 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
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.6750
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Clinical Pulmonary Infection Score (CPIS) at 48 Hours   [ Time Frame: 48 hours ]

Measure Type Secondary
Measure Title Clinical Pulmonary Infection Score (CPIS) at 48 Hours
Measure Description

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.
Time Frame 48 hours  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Vehicle control twice a day (oral rinse)
Chlorhexidine/Placebo Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
Chlorhexidine chlorhexidine 1 oz oral rinse twice a day

Measured Values
    Placebo     Chlorhexidine/Placebo     Chlorhexidine  
Number of Participants Analyzed  
[units: participants]
 		  59     58     58  
Clinical Pulmonary Infection Score (CPIS) at 48 Hours  
[units: units on a scale]
Mean ± Standard Deviation 		  2.5  ± 1     2.5  ± 0.9     2.4  ± 1  

No statistical analysis provided for Clinical Pulmonary Infection Score (CPIS) at 48 Hours




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Frank A. Scannapieco
Organization: University at Buffalo
phone: 716-829-3373
e-mail: fas1@buffalo.edu


Publications of Results:


Responsible Party: Frank A Scannapieco, DMD, Ph.D, University of Buffalo
ClinicalTrials.gov Identifier: NCT00123123     History of Changes
Other Study ID Numbers: NIDCR-14685, R01DE014685, 1R01-DE-14685-1A2
Study First Received: July 21, 2005
Results First Received: August 12, 2010
Last Updated: August 12, 2010
Health Authority: United States: Federal Government