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

April 8, 2022 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Blois, France, 41016
        • Blois Hospital
      • Saint-Brieuc, France, 22000
        • Saint-Brieuc Hospital
      • Saint-Nazaire, France, 44606
        • Saint-NazaireHospital
      • Vannes, France, 56017
        • Vannes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in intensive care units

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumonia
Time Frame: 28 days
Diagnosis of pneumonia (Clinical Pulmonary Infection Score > 6, with assessment of the chest radiography by a blinded investigator)
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pulmonary Infection Score > 6
Time Frame: day 3
day 3
Acute respiratory distress syndrome
Time Frame: day 90
PaO2/FiO2 < 200 with a PEEP > 5 (Berlin definition)
day 90
Duration of mechanical ventilation
Time Frame: day 90
day 90
Intensive Care unit Length of stay
Time Frame: day 90
day 90
Mortality
Time Frame: day 90
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Antoine ROQUILLY, PH, Nantes university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

April 21, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (ESTIMATE)

March 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC15_0081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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