Bronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia (CBF et PAVMt)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Grenoble
Sponsor:
University Hospital, Grenoble
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01770015
First received: June 21, 2012
Last updated: January 16, 2013
Last verified: January 2013
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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: | 600 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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
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: TOURNEGROS caroline, ARC 0476767109 CTournegros@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: | January 16, 2013 |
| 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 June 17, 2013