- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442023
Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%
March 8, 2019 updated by: Jose Antonio de Jesus Alvarez Canales, Universidad de Guanajuato
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%
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
74
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marco A López, MD
- Phone Number: 524641212911
- Email: blackadam_@hotmail.com
Study Locations
-
-
Guanajuato
-
Leon, Guanajuato, Mexico, 37000
- Recruiting
- University of Guanajuato
-
Contact:
- Jose A Alvarez, PhD
- Phone Number: +52-477-259 45 98
- Email: alvarez_ja@me.com
-
Contact:
- Marco A Garcia, MD
- Phone Number: +52-477-259 45 98
- Email: blackadam_@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Chlorhexidine 2%
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%
|
Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.
|
ACTIVE_COMPARATOR: Chlorhexidine 0.12%
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%
|
Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gram-negative decolonization rate
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2019
Primary Completion (ANTICIPATED)
November 1, 2019
Study Completion (ANTICIPATED)
December 1, 2019
Study Registration Dates
First Submitted
February 15, 2018
First Submitted That Met QC Criteria
February 15, 2018
First Posted (ACTUAL)
February 22, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Disease Attributes
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia, Ventilator-Associated
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- SSGTO00153
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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