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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%

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%

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03442023
Enrollment
74
Registered
2018-02-22
Start date
2019-02-01
Completion date
2019-12-31
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlorhexidine, Ventilator Associated Pneumonia

Keywords

Chlorhexidine, Gram-negative, Colonization

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.

Interventions

DRUGChlorhexidine gluconate at 2%

Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.

DRUGChlorhexidine gluconate at 0.12%

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

Sponsors

Universidad de Guanajuato
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gram-negative decolonization rate2 weeksPatients 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 rate2 weeksPatients 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.

Countries

Mexico

Contacts

Primary ContactJosé A Álvarez, PhD
alvarez_ja@me.com52 477 2674900
Backup ContactMarco A López, MD
blackadam_@hotmail.com524641212911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026