Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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:
- 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 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: | January 28, 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 May 23, 2013