Microbial and Pharmacological Assessment of Chlorhexidine

September 21, 2017 updated by: Prof Jean-Damien RICARD, Hôpital Louis Mourier

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
study population
Consecutive critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
changes over time of bacterial growth
Time Frame: 6 hours (360 minutes)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes over time of bacterial growth of each bacterial specie
Time Frame: 6 hours (360 minutes)
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)
susceptibility of isolates to chlorhexidine
Time Frame: 1 hour
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
salivary concentration of chlorhexidine
Time Frame: 6 hours (360 minutes)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital Louis Mourier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HLM_JDR7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia, Ventilator-Associated

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings