Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-09 @ 9:05 AM
Study NCT ID:
NCT03290105
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbial and Pharmacological Assessment of Chlorhexidine
Sponsor:
Hôpital Louis Mourier
Organization:
Study Overview
Official Title:
Efficacy of Chlorhexidine Mouth Wash in ICU Ventilated Patients: Microbiological Effects and Antiseptic Residual Concentrations
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in patients' saliva at the same time-points after CMW.
Detailed Description:
Ventilator associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Although many guidelines and expert opinions recommend oral hygiene with chlorhexidine, optimal conditions of CMW use remain unknown. In addition, precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in the saliva at the same time-points after CMW.
In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine solution.
Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2 hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial growth.
In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.
In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine solution.
Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2 hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial growth.
In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: