Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN) (PYO GEN)

November 7, 2022 updated by: University Hospital, Grenoble

Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia

Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study.

The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.

Study Overview

Detailed Description

The presence of environmental reservoirs can cause infections and multidrug-resistant P. aeruginosa colonization with P. aeruginosa is itself a prognostic factor, but the impact of the route of infection on the evolution of the history and future of the infectious patient is not established.

A second factor that may influence the evolution infectious is the degree of genetic heterogeneity of the bacterial population. Multiple exposure pathways could also influence the genetic diversity.

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Isère
      • Grenoble, Isère, France, 38700
        • Medical ICU of Universitary Hospital of Grenoble

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients over 72 hours of intubation and mechanically ventilated

Description

Inclusion Criteria:

  • Patients> 18 years
  • hospitalized in the intensive care unit
  • with more than 72 hours of mechanical ventilation
  • Presenting a positive bacteriological sample P. aeruginosa.

Exclusion Criteria:

  • Minors.
  • Pregnant or lactating women.
  • Patients under guardianship, under judiciary placement, or hospitalized without their consent.
  • Patients not affiliated to a social security scheme.
  • Long-term corticosteroid therapy (> 2mg/kg or> 1 month before the onset of established infection suspected)
  • Ongoing chemotherapy, AIDS, transplant patient under immunosuppressive drugs.
  • Bedridden patient or therapeutic decision at ICU arrival

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

Cohorts and Interventions

Group / Cohort
Intubated ICU patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of unfavorable patient's outcome, depending on the mode of contamination, such as persistence, relapse or superinfection of the airways at Day 7, and mortality at Day 28
Time Frame: From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).
From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of different clones of P. aeruginosa found in each sample analyzed for the same patient at diagnosis of colonization and VAP.
Time Frame: From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).
Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%
From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).

Collaborators and Investigators

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

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

July 3, 2013

Primary Completion (Actual)

June 2, 2015

Study Completion (Actual)

June 2, 2015

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

May 1, 2022

More Information

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.

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