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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03442023
Other study ID # SSGTO00153
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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