Impact of the Contamination Mode on the Clinical Evolutio... | NCT01745796

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

NCT01745796

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Nov 8, 2022Actual

Enrollment

77Actual

Phase

Not provided

Conditions

Pseudomonas Aeruginosa
Ventilation Acquired Pneumonia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2013

Primary Completion Date

Jun 2, 2015Actual

Completion Date

Jun 2, 2015Actual

First Submitted Date

Oct 8, 2012

First Submission Date that Met QC Criteria

Dec 6, 2012

First Posted Date

Dec 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2022

Last Update Posted Date

Nov 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

77Actual

Label	Type	Description	Intervention Names
Intubated ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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.	Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%	From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU patients over 72 hours of intubation and mechanically ventilated

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical ICU of Universitary Hospital of Grenoble		Grenoble	Isère	38700	France

Condition Browse Module

MeSH Terms

ID	Term
D011552	Pseudomonas Infections

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.