- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745796
Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN) (PYO GEN)
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
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Isère
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Grenoble, Isère, France, 38700
- Medical ICU of Universitary Hospital of Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Intubated ICU patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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).
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From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).
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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).
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Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%
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From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia
- Pneumonia, Ventilator-Associated
- Pseudomonas Infections
Other Study ID Numbers
- 12SC02
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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