Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

December 7, 2015 updated by: Jesús Javier Martínez-García, Sinaloa Pediatric Hospital

Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.

To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80200
        • Recruiting
        • Sinaloa Pediatric Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesus J Martinez, MD

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

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 1 month to 18 years admitted to the intensive care unit.
  • Intubated for more than 48 hours.

Exclusion Criteria:

  • Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
  • Allergy to chlorhexidine.
  • Known immune deficiency.

Elimination Criteria:

  • Transfer to another hospital.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.12% Chlorhexidine
Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.
Drug: 0.12% chlorhexidine solution
Bexident® (0.12% chlorhexidine solution)
Other Names:
  • Peridex, Betasept, PerioGard.
Placebo Comparator: Placebo
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
Drug: Placebo
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ventilator associated pneumonia
Time Frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Days of mechanical ventilation
Time Frame: From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
Length of stay
Time Frame: From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks
From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinaloa Pediatric Hospital

Investigators

  • Study Chair: Jesus J Martinez, MD, Sinaloa Pediatric Hospital

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

October 1, 2012

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPS-02

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.

Clinical Trials on Mechanical Ventilation for More Than 48 Hours.

Clinical Trials on 0.12% chlorhexidine solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe