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Bronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia (CBF et PAVMt)

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ClinicalTrials.gov Identifier: NCT01770015
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Ventilator Acquired Pneumonia Procedure: biological sampling Procedure: sampling blood Procedure: endotracheal aspiration Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia
Study Start Date : November 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ventilated patient

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

Procedure: biological sampling
cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization
Procedure: sampling blood
HLA DR antigen, cytokines (IL 6 and 10), B-glucan
Procedure: endotracheal aspiration
fungi and bacteria endotracheal aspiration



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770015


Locations
France
Hospital University Clermont Ferrand Gabriel Montpied
Clermont-Ferrand, France, 63001
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: TIMSIT Jean-François, PU/PH University Hospital, Grenoble

Responsible Party: AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01770015     History of Changes
Other Study ID Numbers: 2011-A00767-34
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AdministrateurDRC, University Hospital, Grenoble:
patient ventilated for at least five days

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury