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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT01770015
Collaborator
(none)
213
Enrollment
2
Locations
1
Arm
58
Duration (Months)
106.5
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: biological sampling
  • Procedure: sampling blood
  • Procedure: endotracheal aspiration
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
213 participants
Allocation:
N/A
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 :
Nov 1, 2011
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Onset of a late ventilator acquired pneumonia (VAP) [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 [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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital University Clermont Ferrand Gabriel Montpied Clermont-Ferrand France 63001
2 University Hospital of Grenoble Grenoble France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: TIMSIT Jean-François, PU/PH, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01770015
Other Study ID Numbers:
  • 2011-A00767-34
First Posted:
Jan 17, 2013
Last Update Posted:
Jan 4, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
patient ventilated for at least five days
Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated

Study Results

No Results Posted as of Jan 4, 2017