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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01745796
First received: October 8, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition
Pseudomonas Aeruginosa
Ventilation Acquired Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%


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.


Estimated Enrollment: 180
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intubated ICU patients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ICU patients over 72 hours of intubation and mechanically ventilated

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745796

Locations
France
Medical ICU of Universitary Hospital of Grenoble Recruiting
Grenoble, Isère, France, 38700
Contact: CALVINO CS Silvia, IDE       SCalvino-gunther@chu-grenoble.fr   
Principal Investigator: TIMSIT JFT Jean-françois         
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01745796     History of Changes
Other Study ID Numbers: 12SC02
Study First Received: October 8, 2012
Last Updated: October 18, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Grenoble:
Pseudomonas Aeruginosa
Ventilated Acquired Pneumonia
Transmission modes

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Pseudomonas Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on October 01, 2014