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

NCT03442023 | Unknown Phase 3

• 1 other identifier: SSGTO00153
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlorhexidine; Ventilator Associated Pneumonia

Keywords

Chlorhexidine; Gram-negative; Colonization

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Chlorhexidine 2%

EXPERIMENTAL

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%

Chlorhexidine 0.12%

ACTIVE COMPARATOR

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%

Interventions

Chlorhexidine gluconate at 2% DRUG

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

Chlorhexidine 2%

Chlorhexidine gluconate at 0.12% DRUG

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

Chlorhexidine 0.12%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who wish to withdraw consent and leave the study.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

University of Guanajuato

León, Guanajuato, 37000, Mexico

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose A Alvarez, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José A Álvarez, PhD

CONTACT

52 477 2674900; alvarez_ja@me.com

Marco A López, MD

CONTACT

524641212911; blackadam_@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, MSCR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: February 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

ME (1)