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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01770015
Other study ID # 2011-A00767-34
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date September 2016

Study information

Verified date November 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date September 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
France Hospital University Clermont Ferrand Gabriel Montpied Clermont-Ferrand
France University Hospital of Grenoble Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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