NCT02717767

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

March 14, 2016

Last Update Submit

April 8, 2022

Conditions

Keywords

pneumoniadiagnosisprognosistracheal aspiratebronchoalveolar lavage

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

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Saint-Brieuc Hospital

Saint-Brieuc, 22000, France

Location

Saint-NazaireHospital

Saint-Nazaire, 44606, France

Location

Vannes Hospital

Vannes, 56017, France

Location

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

Retention: SAMPLES WITHOUT DNA

tracheal aspirate and bronchoalveolar lavages

MeSH Terms

Conditions

PneumoniaDisease

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine ROQUILLY, PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations