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NCT02717767 Clinical Trial

Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU

Pneumonia Clinical Trial

— BIONAGA  

Official title:
Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02717767
Other study ID # RC15_0081
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date May 2017

Study information
Verified date April 2022
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of white corpuscles is altered during pneumonia. In presence of bacterial growth on lung samples, the measure of autofluorescence of white corpuscles could help the clinicians to discriminate bacterial colonization from acute infection.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date May 2017
Est. primary completion date April 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Hospitalization in intensive care units - Mechanical ventilation - Age > 18 years - Collection of a lung sample for bacteriological analysis for the suspicion of a first episode of lung infection. Exclusion Criteria: - Refuse to participate

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Autofluorescence of white corpuscle
Measure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages

Locations
Country Name City State
France Blois Hospital Blois
France Saint-Brieuc Hospital Saint-Brieuc
France Saint-NazaireHospital Saint-Nazaire
France Vannes Hospital Vannes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

Monsel A, Lécart S, Roquilly A, Broquet A, Jacqueline C, Mirault T, Troude T, Fontaine-Aupart MP, Asehnoune K. Analysis of autofluorescence in polymorphonuclear neutrophils: a new tool for early infection diagnosis. PLoS One. 2014 Mar 21;9(3):e92564. doi: 10.1371/journal.pone.0092564. eCollection 2014. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pneumonia Diagnosis of pneumonia (Clinical Pulmonary Infection Score > 6, with assessment of the chest radiography by a blinded investigator) 28 days
Secondary Clinical Pulmonary Infection Score > 6 day 3
Secondary Acute respiratory distress syndrome PaO2/FiO2 < 200 with a PEEP > 5 (Berlin definition) day 90
Secondary Duration of mechanical ventilation day 90
Secondary Intensive Care unit Length of stay day 90
Secondary Mortality day 90
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