Microbial and Pharmacological Assessment of Chlorhexidine

NCT03290105 | Completed

• 1 other identifier: HLM_JDR7
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

oropharyngeal colonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• changes over time of bacterial growth of each bacterial specie

  6 hours (360 minutes)

• susceptibility of isolates to chlorhexidine

  1 hour

• salivary concentration of chlorhexidine

  6 hours (360 minutes)

Study Arms (1)

study population

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours
• cervical or mouth surgery in the last 15 days;
• history of oropharyngeal neoplasm or of cervical or oropharyngeal radiotherapy,
• tracheotomy,
• age under 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Louis Mourier: lead

Related Publications (2)

• 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.

  PMID: 28578560 BACKGROUND

• 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.

  PMID: 24663255 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva for measurement of chlorhexidine concentration; swabbing of oropharyngeal secretions

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Bacterial Infections

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Jean-Damien Ricard, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Béatrice La Combe, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: January 27, 2014
• Primary Completion: March 31, 2014
• Study Completion: June 1, 2016
• Last Updated: September 25, 2017

Record last verified: 2017-09