NCT00597688

Brief Summary

The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 23, 2011

Status Verified

February 1, 2009

Enrollment Period

1.4 years

First QC Date

January 10, 2008

Last Update Submit

March 22, 2011

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria

    21 days

Secondary Outcomes (4)

  • Antibiotic sensitivity of organism cultured

    21 days

  • Duration of hospital stay

    21 days

  • Duration of ICU stay

    21 days

  • In hospital mortality rate

    21 days

Study Arms (2)

1

ACTIVE COMPARATOR

Chlorhexidine gel

Drug: Chlorhexidine gel

2

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo gel

Interventions

Chlorhexidine gelDRUG

Oral mucosal application of chlorhexidine gel

1
Placebo gelDRUG

Oral mucosal application of placebo gel

2

Eligibility Criteria

Age3 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients in PICU requiring mechanical ventilation
  • Above the age of 3 months
  • Oro or nasotracheal intubation

You may not qualify if:

  • Known hypersensitivity to chlorhexidine
  • Inability to access the oral cavity for any reason
  • Patients with tracheostomy
  • Mechanical ventilation for more than 24 hours prior to PICU admission.
  • Death or extubation within 24 hours of ICU admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

  • Sebastian MR, Lodha R, Kapil A, Kabra SK. Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial. Pediatr Crit Care Med. 2012 Sep;13(5):e305-10. doi: 10.1097/PCC.0b013e31824ea119.

    PMID: 22760426DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • RAKESH LODHA

    All India Institute of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 18, 2008

Study Start

November 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 23, 2011

Record last verified: 2009-02

Locations

IN(1)