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

NCT01745796 | Completed

• 1 other identifier: 12SC02
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pseudomonas Aeruginosa; Ventilation Acquired Pneumonia

Keywords

Pseudomonas Aeruginosa; Ventilated Acquired Pneumonia; Transmission modes

Outcome Measures

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

  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.

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

Study Arms (1)

Intubated ICU patients

Eligibility Criteria

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

Study Population

ICU patients over 72 hours of intubation and mechanically ventilated

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Medical ICU of Universitary Hospital of Grenoble

Grenoble, Isère, 38700, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In order to achieve an antibiogram according to conventional methods and PCR genotyping Rep (DiversiLab ®) to assess the clonality of bacterial populations, there will be taken 5 different isolated colonies (possibly diluted)from each clinical sample of bronchial secretion, selected according to morphological criteria or randomly if no visible differences are noted.

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: December 10, 2012
• Study Start: July 3, 2013
• Primary Completion: June 2, 2015
• Study Completion: June 2, 2015
• Last Updated: November 8, 2022

Record last verified: 2022-05

Locations

FR (1)