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CompletedNCT01745796PYO GENUpdated Nov 8, 2022

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

An observational study in Pseudomonas Aeruginosa and Ventilation Acquired Pneumonia, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pseudomonas Aeruginosa
  • Ventilation Acquired Pneumonia

Keywords

  • Pseudomonas Aeruginosa
  • Ventilated Acquired Pneumonia
  • Transmission modes
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 77 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU patients over 72 hours of intubation and mechanically ventilated

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Intubated ICU patients
06

What researchers measure

Primary outcomes

  1. 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).

Secondary outcomes

  1. Number of different clones of P. aeruginosa found in each sample analyzed for the same patient at diagnosis of colonization and VAP.

    Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%

    Time frame: From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).

07

Study locations

1 site
  • Medical ICU of Universitary Hospital of Grenoble
    Grenoble, Isère 38700, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01745796
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Dec 10, 2012
Start date
Jul 3, 2013
Primary completion
Jun 2, 2015
Completion
Jun 2, 2015
Last update
Nov 8, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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