NCT01883596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

June 11, 2013

Last Update Submit

December 7, 2015

Conditions

Mechanical Ventilation for More Than 48 Hours.

Outcome Measures

Primary Outcomes (1)

  • Incidence of ventilator associated pneumonia

    Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks

Secondary Outcomes (3)

  • Mortality

    Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks

  • 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

  • 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

Study Arms (2)

0.12% Chlorhexidine

EXPERIMENTAL

Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.

Drug: 0.12% chlorhexidine solution

Placebo

PLACEBO COMPARATOR

7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.

Drug: Placebo

Interventions

0.12% chlorhexidine solutionDRUG

Bexident® (0.12% chlorhexidine solution)

Also known as: Peridex, Betasept, PerioGard.
0.12% Chlorhexidine
PlaceboDRUG

7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.

Placebo

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
  • Allergy to chlorhexidine.
  • Known immune deficiency.
  • Elimination Criteria:
  • Transfer to another hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinaloa Pediatric Hospital

Culiacán, Sinaloa, 80200, Mexico

RECRUITING

MeSH Terms

Interventions

chlorhexidine gluconateChlorhexidine

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jesus J Martinez, MD

    Sinaloa Pediatric Hospital

    STUDY CHAIR

Central Study Contacts

Jesus J Martinez, MD

CONTACT

+52 (667) 7139004jjmtz64@hotmail.com

Luz I Zamudio, MD

CONTACT

+52 (667) 7164686zluz_isabel@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 21, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

ME(1)