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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717767
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Pneumonia Other: Autofluorescence of white corpuscle

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in Intensive Care Units
Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia


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


Primary Outcome Measures :
  1. Pneumonia [ Time Frame: 28 days ]
    Diagnosis of pneumonia (Clinical Pulmonary Infection Score > 6, with assessment of the chest radiography by a blinded investigator)


Secondary Outcome Measures :
  1. Clinical Pulmonary Infection Score > 6 [ Time Frame: day 3 ]
  2. Acute respiratory distress syndrome [ Time Frame: day 90 ]
    PaO2/FiO2 < 200 with a PEEP > 5 (Berlin definition)

  3. Duration of mechanical ventilation [ Time Frame: day 90 ]
  4. Intensive Care unit Length of stay [ Time Frame: day 90 ]
  5. Mortality [ Time Frame: day 90 ]

Biospecimen Retention:   Samples Without DNA
tracheal aspirate and bronchoalveolar lavages


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in intensive care units
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717767


Locations
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France
Blois Hospital
Blois, France, 41016
Saint-Brieuc Hospital
Saint-Brieuc, France, 22000
Saint-NazaireHospital
Saint-Nazaire, France, 44606
Vannes Hospital
Vannes, France, 56017
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Antoine ROQUILLY, PH Nantes University Hospital
Publications:
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02717767    
Other Study ID Numbers: RC15_0081
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nantes University Hospital:
pneumonia
diagnosis
prognosis
tracheal aspirate
bronchoalveolar lavage
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections