Pseudomonas AeruginosaPYO GENNCT01745796
Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN)
An observational study of Pseudomonas Aeruginosa and Ventilation Acquired Pneumonia, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas Aeruginosa, Ventilation Acquired Pneumonia
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2013to 2 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients over 72 hours of intubation and mechanically ventilated
Who may be able to join
- Patients> 18 years
- hospitalized in the intensive care unit
- with more than 72 hours of mechanical ventilation
- Presenting a positive bacteriological sample P. aeruginosa.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Medical ICU of Universitary Hospital of Grenoble
Grenoble, Isère, 38700
About this study
Official title: 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.
Read the 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.
- Keywords
- Pseudomonas Aeruginosa, Ventilated Acquired Pneumonia, Transmission modes
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intubated ICU patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%
Measured: From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study start3 Jul 2013
- Primary completion2 Jun 2015
- Study completion2 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas AeruginosaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745796
- Sponsor's protocol ID
- 12SC02
- Acronym
- PYO GEN
- Status last verified
- May 2022
- First submitted
- 8 Oct 2012
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01745796
- Acronym / sponsor ID
- PYO GEN / 12SC02
- Keywords
- Pseudomonas Aeruginosa, Ventilated Acquired Pneumonia, Transmission modes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 3 Jul 2013
- Primary completion
- 2 Jun 2015 (actual)
- Study completion
- 2 Jun 2015 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated ICU patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients over 72 hours of intubation and mechanically ventilated
Key inclusion criteria (4 listed)
- Patients> 18 years
- hospitalized in the intensive care unit
- with more than 72 hours of mechanical ventilation
- Presenting a positive bacteriological sample P. aeruginosa.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomonas Aeruginosa and Ventilation Acquired Pneumonia, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.