Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883596
Recruitment Status : Unknown
Verified December 2015 by Jesús Javier Martínez-García, Sinaloa Pediatric Hospital.
Recruitment status was:  Recruiting
First Posted : June 21, 2013
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Jesús Javier Martínez-García, Sinaloa Pediatric Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation for More Than 48 Hours. Drug: 0.12% chlorhexidine solution Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
Study Start Date : October 2012
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016


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 Name: 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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883596


Contacts
Layout table for location contacts
Contact: Jesus J Martinez, MD +52 (667) 7139004 ext 274 jjmtz64@hotmail.com
Contact: Luz I Zamudio, MD +52 (667) 7164686 zluz_isabel@hotmail.com

Locations
Layout table for location information
Mexico
Sinaloa Pediatric Hospital Recruiting
Culiacan, Sinaloa, Mexico, 80200
Contact: Jesus J Martinez, MD    +52 (667) 7139004 ext 274    jjmtz64@hotmail.com   
Contact: Luz I Zamudio, MD    +52 (667) 7164686    zluz_isabel@hotmail.com   
Principal Investigator: Jesus J Martinez, MD         
Sponsors and Collaborators
Sinaloa Pediatric Hospital
Investigators
Layout table for investigator information
Study Chair: Jesus J Martinez, MD Sinaloa Pediatric Hospital

Layout table for additonal information
Responsible Party: Jesús Javier Martínez-García, MD, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier: NCT01883596    
Other Study ID Numbers: HPS-02
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Chlorhexidine
Chlorhexidine gluconate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents