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

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ClinicalTrials.gov Identifier: NCT03442023
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jose Antonio de Jesus Alvarez Canales, Universidad de Guanajuato

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.

Condition or disease Intervention/treatment Phase
Chlorhexidine Ventilator Associated Pneumonia Drug: Chlorhexidine gluconate at 2% Drug: Chlorhexidine gluconate at 0.12% Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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%
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442023


Contacts
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Contact: José A Álvarez, PhD 52 477 2674900 ext 4643 alvarez_ja@me.com
Contact: Marco A López, MD 524641212911 blackadam_@hotmail.com

Locations
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Mexico
University of Guanajuato Recruiting
Leon, Guanajuato, Mexico, 37000
Contact: Jose A Alvarez, PhD    +52-477-259 45 98    alvarez_ja@me.com   
Contact: Marco A Garcia, MD    +52-477-259 45 98    blackadam_@hotmail.com   
Sponsors and Collaborators
Universidad de Guanajuato
Investigators
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Principal Investigator: Jose A Alvarez, PhD Universidad de Guanajuato

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Responsible Party: Jose Antonio de Jesus Alvarez Canales, PhD, MD, MSCR, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT03442023     History of Changes
Other Study ID Numbers: SSGTO00153
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jose Antonio de Jesus Alvarez Canales, Universidad de Guanajuato:
Chlorhexidine
Gram-negative
Colonization

Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents