INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children

NCT ID: NCT03105414

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-05-15

Brief Summary

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Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults, however, few data exist regarding VAP in the paediatric intensive care population. The Centers for Disease Control (CDC) definition for VAP is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. According to the latest CDC definition, the investigators aim to study incidence of VAP in different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP, microbiology of VAP, and utilisation of empirical antimicrobial therapy.

Methods and population : a prospective multicentre observational study will be conducted in European PICUs for one year. All patients admitted to PICU aged more than 28 days and \< 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet. The investigators are going to identify patients, who presented one or more episodes of VAP during PICUs stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence will be reported as number of events per 1,000 ventilator-days. Risk factors associated to VAP will be identified by univariate and multivariate analysis.

Results and perspective : the investigators aim to define for the first time the incidence of VAP among European PICUs with a prospective and multicentre study. The identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for VAP in paediatric intensive care population.

Detailed Description

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Conditions

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Pneumonia, Ventilator-Associated

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mechanical ventilation

Mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Admitted to Pediatric Intensive Care Unit
* Aged more than 28 days and \< 18 years
* Mechanically ventilated either by endotracheal or tracheostomy tube

Exclusion Criteria

\-
Minimum Eligible Age

28 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sylvie Chevret

OTHER

Sponsor Role lead

Responsible Party

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Sylvie Chevret

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Robert Debré Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphane Dauger, MD

Role: CONTACT

140032000 ext. +33

Matthieu Resche-Rigon, MD

Role: CONTACT

142499742 ext. +33

Facility Contacts

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Stéphane Dauger, MD

Role: primary

1 40 03 21 87 ext. +33

Other Identifiers

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11-362

Identifier Type: -

Identifier Source: org_study_id

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