NCT01770015

Brief Summary

Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side, bronchial fungi colonization is commonly observed in ICU; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of VAP taking into account the immune status of the patient and the antibiotic and antifungal treatments he has received.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

4.3 years

First QC Date

June 21, 2012

Last Update Submit

November 3, 2022

Conditions

Ventilator Acquired Pneumonia

Keywords

patient ventilated for at least five days

Outcome Measures

Primary Outcomes (1)

  • Onset of a late ventilator acquired pneumonia (VAP)

    Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks

Secondary Outcomes (2)

  • Onset of a pseudomonas aeruginosa associated VAP

    Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks

  • Onset of late ventilator associated pneumonia associated to staphylococcus aureus

    Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks

Study Arms (1)

ventilated patient

EXPERIMENTAL

all patients underwent the same diagnostic test . cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization. HLA DR antigen, cytokines (IL 6 and 10), B-glucan. fungi and bacteria endotracheal aspiration

Procedure: biological samplingProcedure: sampling bloodProcedure: endotracheal aspiration

Interventions

biological samplingPROCEDURE

cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization

ventilated patient
sampling bloodPROCEDURE

HLA DR antigen, cytokines (IL 6 and 10), B-glucan

ventilated patient
endotracheal aspirationPROCEDURE

fungi and bacteria endotracheal aspiration

ventilated patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient ventilated for at least 5 days

You may not qualify if:

  • invasive infection Candida sp defined by : candidemia, isolation of Candida from a normally sterile site, candida pneumoniae.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital University Clermont Ferrand Gabriel Montpied

Clermont-Ferrand, 63001, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • Timsit JF, Schwebel C, Styfalova L, Cornet M, Poirier P, Forrestier C, Ruckly S, Jacob MC, Souweine B. Impact of bronchial colonization with Candida spp. on the risk of bacterial ventilator-associated pneumonia in the ICU: the FUNGIBACT prospective cohort study. Intensive Care Med. 2019 Jun;45(6):834-843. doi: 10.1007/s00134-019-05622-0. Epub 2019 Apr 24.

    PMID: 31020361DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisParacentesisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • TIMSIT Jean-François, PU/PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr JF TIMSIT

Study Record Dates

First Submitted

June 21, 2012

First Posted

January 17, 2013

Study Start

November 1, 2011

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)