Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU
BIONAGA
1 other identifier
observational
69
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2016
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedApril 11, 2022
April 1, 2022
10 months
March 14, 2016
April 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pneumonia
Diagnosis of pneumonia (Clinical Pulmonary Infection Score \> 6, with assessment of the chest radiography by a blinded investigator)
28 days
Secondary Outcomes (5)
Clinical Pulmonary Infection Score > 6
day 3
Acute respiratory distress syndrome
day 90
Duration of mechanical ventilation
day 90
Intensive Care unit Length of stay
day 90
Mortality
day 90
Interventions
Measure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages
Eligibility Criteria
Patients in intensive care units
You may qualify if:
- 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.
You may not qualify if:
- Refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Blois Hospital
Blois, 41016, France
Saint-Brieuc Hospital
Saint-Brieuc, 22000, France
Saint-NazaireHospital
Saint-Nazaire, 44606, France
Vannes Hospital
Vannes, 56017, France
Related Publications (1)
Monsel A, Lecart 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.
PMID: 24658436BACKGROUND
Biospecimen
tracheal aspirate and bronchoalveolar lavages
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine ROQUILLY, PH
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 24, 2016
Study Start
July 1, 2016
Primary Completion
April 21, 2017
Study Completion
May 1, 2017
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share