PneumoniaBIONAGANCT02717767
Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU
An observational study of Pneumonia, run by Nantes University Hospital at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Autofluorescence of white corpuscle
- How many people
- 69 participants
- Where
- 4 sitesFrance
- Study dates
- Jul 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in intensive care units
Who may be able to join
- 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.
Who cannot join
- Refuse to participate
Trial locations and contacts
4 sites in 1 country.
France4 sites
Blois Hospital
Blois, 41016
Saint-Brieuc Hospital
Saint-Brieuc, 22000
Saint-NazaireHospital
Saint-Nazaire, 44606
Vannes Hospital
Vannes, 56017
About this study
Official title: 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.
- Conditions
- Pneumonia
- Being tested
- Autofluorescence of white corpuscle
- Keywords
- pneumonia, diagnosis, prognosis, tracheal aspirate, bronchoalveolar lavage
- Medical subject headings
- Pneumonia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autofluorescence of white corpuscleOther
Measure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia
Diagnosis of pneumonia (Clinical Pulmonary Infection Score > 6, with assessment of the chest radiography by a blinded investigator)
Measured: 28 days
Secondary outcomes (5)
Clinical Pulmonary Infection Score > 6
Measured: day 3
Acute respiratory distress syndrome
PaO2/FiO2 < 200 with a PEEP > 5 (Berlin definition)
Measured: day 90
Duration of mechanical ventilation
Measured: day 90
Intensive Care unit Length of stay
Measured: day 90
Mortality
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startJul 2016
- Primary completion21 Apr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ROQUILLY, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717767
- Sponsor's protocol ID
- RC15_0081
- Acronym
- BIONAGA
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2016
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24658436
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in Intensive Care Units
- ClinicalTrials.gov ID
- NCT02717767
- Acronym / sponsor ID
- BIONAGA / RC15_0081
- Conditions
- Pneumonia
- Keywords
- pneumonia, diagnosis, prognosis, tracheal aspirate, bronchoalveolar lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care units
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autofluorescence of white corpuscleMeasure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages | Other | – |
Primary outcome
Pneumonia
Time frame: 28 days
Diagnosis of pneumonia (Clinical Pulmonary Infection Score > 6, with assessment of the chest radiography by a blinded investigator)
5 secondary outcomes
Clinical Pulmonary Infection Score > 6
Time frame: day 3
Acute respiratory distress syndrome
Time frame: day 90
Duration of mechanical ventilation
Time frame: day 90
Intensive Care unit Length of stay
Time frame: day 90
Mortality
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 24658436Monsel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine ROQUILLY, PH principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Nantes University Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.