Microbial and Pharmacological Assessment of Chlorhexidine

Infection, Bacterial Clinical Trial

Official title:

Efficacy of Chlorhexidine Mouth Wash in ICU Ventilated Patients: Microbiological Effects and Antiseptic Residual Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290105
• Other study ID #: HLM_JDR7
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: September 21, 2017
• Start date: January 27, 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: September 2017
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2016
• Est. primary completion date: March 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours

Non-inclusion criteria:

• cervical or mouth surgery in the last 15 days;

• history of oropharyngeal neoplasm or of cervical or oropharyngeal radiotherapy,

• tracheotomy,

• age under 18

Exclusion Criteria:

• Patients whose samples retrieved less than 10 to the 3 colony forming unit (CFU)/mL bacteria and those who had two or more missing microbiological samples were secondarily excluded

Related Conditions & MeSH terms

• Bacterial Infections
• Bacterium; Agent
• Chlorhexidine
• Infection, Bacterial
• Oropharynx Abnormality
• Pneumonia
• Pneumonia, Ventilator-Associated

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

References & Publications (2)

Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359. Review. — View Citation

Klompas M. Oropharyngeal Decontamination with Antiseptics to Prevent Ventilator-Associated Pneumonia: Rethinking the Benefits of Chlorhexidine. Semin Respir Crit Care Med. 2017 Jun;38(3):381-390. doi: 10.1055/s-0037-1602584. Epub 2017 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes over time of bacterial growth	oropharyngeal colonization (i.e., amount of bacterial growth in each oropharyngeal sample) before and after a mouth wash with chlorhexidine will be measured at different time points (before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine)	6 hours (360 minutes)
Secondary	changes over time of bacterial growth of each bacterial specie	changes over time in bacterial growth of each bacterial species isolated in the oropharynx will be measured before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine	6 hours (360 minutes)
Secondary	susceptibility of isolates to chlorhexidine	chlorhexidine minimal inhibitory concentration of dominant pathogens of each patient will be determined using the broth microdilution method recommended by the Clinical & Laboratory Standards Institute	1 hour
Secondary	salivary concentration of chlorhexidine	salivary concentration of chlorhexidine will be measured 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine using high-pressure liquid chromatography	6 hours (360 minutes)