Ventilator Acquired PneumoniaCBF et PAVMtNCT01770015
Bronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia
A study testing biological sampling, sampling blood and endotracheal aspiration in people with Ventilator Acquired Pneumonia, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side, bronchial fungi colonization is commonly observed in ICU; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of VAP taking into account the immune status of the patient and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Acquired Pneumonia
- What is being tested?
- biological sampling, sampling blood and endotracheal aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2011to Sep 2016
- Phase
- Interventional
- 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
Who may be able to join
- patient ventilated for at least 5 days
Who cannot join
- invasive infection Candida sp defined by : candidemia, isolation of Candida from a normally sterile site, candida pneumoniae.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital University Clermont Ferrand Gabriel Montpied
Clermont-Ferrand, 63001
University Hospital of Grenoble
Grenoble, 38043
About this study
Official title: Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia
Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side, bronchial fungi colonization is commonly observed in ICU; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of VAP taking into account the immune status of the patient and the antibiotic and antifungal treatments he has received.
- Conditions
- Ventilator Acquired Pneumonia
- Being tested
- biological sampling, sampling blood, endotracheal aspiration
- Keywords
- patient ventilated for at least five days
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplingProcedure or surgery
cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization
sampling bloodProcedure or surgery
HLA DR antigen, cytokines (IL 6 and 10), B-glucan
endotracheal aspirationProcedure or surgery
fungi and bacteria endotracheal aspiration
| Study group | Role | What they receive |
|---|---|---|
| ventilated patient | Experimental | all patients underwent the same diagnostic test . cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization.
HLA DR antigen, cytokines (IL 6 and 10), B-glucan. fungi and bacteria endotracheal aspiration Receives: Procedure: biological sampling; Procedure: sampling blood; Procedure: endotracheal aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of a late ventilator acquired pneumonia (VAP)
Measured: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
Secondary outcomes (2)
Onset of a pseudomonas aeruginosa associated VAP
Measured: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
Onset of late ventilator associated pneumonia associated to staphylococcus aureus
Measured: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Acquired PneumoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurDRC, University Hospital, Grenoble
- Investigators
- TIMSIT Jean-François, PU/PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770015
- Sponsor's protocol ID
- 2011-A00767-34
- Acronym
- CBF et PAVMt
- Status last verified
- Nov 2022
- First submitted
- 21 Jun 2012
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Timsit JF, Schwebel C, Styfalova L, Cornet M, Poirier P, Forrestier C, Ruckly S, Jacob MC, Souweine B. Impact of bronchial colonization with Candida spp. on the risk of bacterial ventilator-associated pneumonia in the ICU: the FUNGIBACT prospective cohort study. Intensive Care Med. 2019 Jun;45(6):834-843. doi: 10.1007/s00134-019-05622-0. Epub 2019 Apr 24.
PubMed 31020361
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01770015
- Acronym / sponsor ID
- CBF et PAVMt / 2011-A00767-34
- Conditions
- Ventilator Acquired Pneumonia
- Keywords
- patient ventilated for at least five days
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jan 2013 (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.
Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side, bronchial fungi colonization is commonly observed in ICU; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of VAP taking into account the immune status of the patient and the antibiotic and antifungal treatments he has received.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilated patient | Experimental | Procedure: biological sampling, Procedure: sampling blood, Procedure: endotracheal aspirationall patients underwent the same diagnostic test . cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization. HLA DR antigen, cytokines (IL 6 and 10), B-glucan. fungi and bacteria endotracheal aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient ventilated for at least 5 days
Key exclusion criteria (1 listed)
- invasive infection Candida sp defined by : candidemia, isolation of Candida from a normally sterile site, candida pneumoniae.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samplingcutaneous, rectal, nose and mouth swabs to identify potential fungi colonization | Procedure or surgery | ventilated patient |
| sampling bloodHLA DR antigen, cytokines (IL 6 and 10), B-glucan | Procedure or surgery | ventilated patient |
| endotracheal aspirationfungi and bacteria endotracheal aspiration | Procedure or surgery | ventilated patient |
Primary outcome
Onset of a late ventilator acquired pneumonia (VAP)
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
2 secondary outcomes
Onset of a pseudomonas aeruginosa associated VAP
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
Onset of late ventilator associated pneumonia associated to staphylococcus aureus
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
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 4 Nov 2022.
- Derived from this study: PubMed 31020361Timsit JF, Schwebel C, Styfalova L, Cornet M, Poirier P, Forrestier C, Ruckly S, Jacob MC, Souweine B. Impact of bronchial colonization with Candida spp. on the risk of bacterial ventilator-associated pneumonia in the ICU: the FUNGIBACT prospective cohort study. Intensive Care Med. 2019 Jun;45(6):834-843. doi: 10.1007/s00134-019-05622-0. Epub 2019 Apr 24.
- Individual participant dataSharing planned: No
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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.
TIMSIT Jean-François, PU/PH principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological sampling, sampling blood and endotracheal aspiration in people with Ventilator Acquired Pneumonia, run by University Hospital, Grenoble at 2 sites 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 1 inclusion and 1 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 4 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 2 sites 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?
Onset of a late ventilator acquired pneumonia (VAP) (time frame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770015, which also lists 1 linked publication.
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 4 Nov 2022.