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

Ventilator Associated Pneumonia Clinical Trial

Official title:

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%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03442023
• Other study ID #: SSGTO00153
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Universidad de Guanajuato
• Contact: José A Álvarez, PhD
• Phone: 52 477 2674900
• Email: alvarez_ja[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chlorhexidine
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Chlorhexidine gluconate at 2%
Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.
• Chlorhexidine gluconate at 0.12%
Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.

Locations

Country	Name	City	State
Mexico	University of Guanajuato	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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