Back to resultsBronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia (CBF et PAVMt)
Primary Purpose
Ventilator Acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological sampling
sampling blood
endotracheal aspiration
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilator Acquired Pneumonia focused on measuring patient ventilated for at least five days
Eligibility Criteria
Inclusion Criteria:
- patient ventilated for at least 5 days
Exclusion Criteria:
- invasive infection Candida sp defined by : candidemia, isolation of Candida from a normally sterile site, candida pneumoniae.
Sites / Locations
- Hospital University Clermont Ferrand Gabriel Montpied
- University Hospital of Grenoble
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ventilated patient
Arm Description
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
Outcomes
Primary Outcome Measures
Onset of a late ventilator acquired pneumonia (VAP)
Secondary Outcome Measures
Onset of a pseudomonas aeruginosa associated VAP
Onset of late ventilator associated pneumonia associated to staphylococcus aureus
Full Information
NCT ID
NCT01770015
First Posted
June 21, 2012
Last Updated
November 3, 2022
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT01770015
Brief Title
Bronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia
Acronym
CBF et PAVMt
Official Title
Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 antibiotic and antifungal treatments he has received.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Acquired Pneumonia
Keywords
patient ventilated for at least five days
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ventilated patient
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
biological sampling
Intervention Description
cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization
Intervention Type
Procedure
Intervention Name(s)
sampling blood
Intervention Description
HLA DR antigen, cytokines (IL 6 and 10), B-glucan
Intervention Type
Procedure
Intervention Name(s)
endotracheal aspiration
Intervention Description
fungi and bacteria endotracheal aspiration
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient ventilated for at least 5 days
Exclusion Criteria:
invasive infection Candida sp defined by : candidemia, isolation of Candida from a normally sterile site, candida pneumoniae.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TIMSIT Jean-François, PU/PH
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital University Clermont Ferrand Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63001
Country
France
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31020361
Citation
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.
Results Reference
derived
Learn more about this trial
Bronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia
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