Back to resultsDifferent Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%
Primary Purpose
Chlorhexidine, Ventilator Associated Pneumonia
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Chlorhexidine gluconate at 2%
Chlorhexidine gluconate at 0.12%
Sponsored by
About this trial
This is an interventional treatment trial for Chlorhexidine focused on measuring Chlorhexidine, Gram-negative, Colonization
Eligibility Criteria
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.
Sites / Locations
- University of GuanajuatoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chlorhexidine 2%
Chlorhexidine 0.12%
Arm Description
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%
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%
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03442023
First Posted
February 15, 2018
Last Updated
March 8, 2019
Sponsor
Universidad de Guanajuato
1. Study Identification
Unique Protocol Identification Number
NCT03442023
Brief Title
Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%
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%
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Guanajuato
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlorhexidine, Ventilator Associated Pneumonia
Keywords
Chlorhexidine, Gram-negative, Colonization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine 2%
Arm Type
Experimental
Arm Description
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%
Arm Title
Chlorhexidine 0.12%
Arm Type
Active Comparator
Arm Description
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%
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate at 2%
Intervention Description
Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate at 0.12%
Intervention Description
Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.
Primary Outcome Measure Information:
Title
Gram-negative decolonization rate
Description
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.
Time Frame
2 weeks
Title
Gram-negative colonization rate
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José A Álvarez, PhD
Phone
52 477 2674900
Ext
4643
Email
alvarez_ja@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marco A López, MD
Phone
524641212911
Email
blackadam_@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Alvarez, PhD
Organizational Affiliation
Universidad de Guanajuato
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guanajuato
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose A Alvarez, PhD
Phone
+52-477-259 45 98
Email
alvarez_ja@me.com
First Name & Middle Initial & Last Name & Degree
Marco A Garcia, MD
Phone
+52-477-259 45 98
Email
blackadam_@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%
We'll reach out to this number within 24 hrs