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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01770015
First received: June 21, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention
Ventilator Acquired Pneumonia
Procedure: biological sampling
Procedure: sampling blood
Procedure: endotracheal aspiration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ventilated patient 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770015

Contacts
Contact: Timsit Jean-Francois, PU/PH 0476768779 jftimsit@chu-grenoble.fr

Locations
France
University Hospital of Grenoble Recruiting
Grenoble, France, 38043
Contact: TIMSIT Jean-Francois, PU/PH    0476768779    JFTimsit@chu-grenoble.fr   
Contact: STYFALOVA Lenka, ARC    0476767109    lstyfalova@chu-grenoble.fr   
Sub-Investigator: HAMIDFAR Rebecca, PH         
Sub-Investigator: PELLOUX Hervé, PU/PH         
Sub-Investigator: CORNET Muriel, PH         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: TIMSIT Jean-François, PU/PH University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01770015     History of Changes
Other Study ID Numbers: 2011-A00767-34
Study First Received: June 21, 2012
Last Updated: July 16, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by 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

ClinicalTrials.gov processed this record on September 14, 2014