Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%

Study Overview
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Brief Summary
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This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-desirable condition that leads to higher mortality rates and longer hospitalization times. One group will receive the 0.12% chlorhexidine mouthwash and the other group will receive the 2% chlorhexidine mouthwash.

Official Title
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Differences Between Oral Colonization Rates of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine Mouthwash at 0.12% Versus Chlorhexidine Mouthwash at 2.0%

Conditions
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Chlorhexidine, Ventilator Associated Pneumonia

Intervention / Treatment
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* Drug: Chlorhexidine gluconate at 2%
* Drug: Chlorhexidine gluconate at 0.12%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with minimum required age of consent that were admitted to the intensive care unit and who received at least 48 hours of mechanical ventilation. Exclusion Criteria: Patients who wish to withdraw consent and leave the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine 2%<br>Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 2% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 2% | Drug: Chlorhexidine gluconate at 2%<br>* Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.<br>|
| Active Comparator: Chlorhexidine 0.12%<br>Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 0.12% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 0.12% | Drug: Chlorhexidine gluconate at 0.12%<br>* Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gram-negative decolonization rate | Patients admitted to the ICU who were originally colonized with gram-negative bacteria and at the end of the study are no longer colonized by gram-negative bacteria. | 2 weeks | 
| Gram-negative colonization rate | Patients admitted to the ICU who were originally not colonized with gram-negative bacteria and at the end of the study are colonized by gram-negative bacteria. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Gram-negative, Colonization