Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

Mechanical Ventilation for More Than 48 Hours. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01883596
• Other study ID #: HPS-02
• Status: Recruiting
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: December 7, 2015
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Sinaloa Pediatric Hospital
• Contact: Jesus J Martinez, MD
• Phone: +52 (667) 7139004
• Email: jjmtz64[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation for More Than 48 Hours.
• Pneumonia, Ventilator-Associated

Intervention

Drug:
• 0.12% chlorhexidine solution
Bexident® (0.12% chlorhexidine solution)
• Placebo
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.

Locations

Country	Name	City	State
Mexico	Sinaloa Pediatric Hospital	Culiacan	Sinaloa

Sponsors (1)

Lead Sponsor	Collaborator
Sinaloa Pediatric Hospital

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ventilator associated pneumonia		Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks	No
Secondary	Mortality		Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks	No
Secondary	Days of mechanical ventilation		From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks	No
Secondary	Length of stay		From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks	No