INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children

Pneumonia, Ventilator-Associated Clinical Trial

— INCIPAVE  

Official title:

Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105414
• Other study ID #: 11-362
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: May 8, 2017
• Start date: April 3, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Stéphane Dauger, MD
• Phone: 140032000
• Email: stephane.dauger[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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:

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Device:
• Mechanical ventilation
Mechanical ventilation

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sylvie Chevret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ventilator acquired pneumonia	CDC definition of ventilator acquired pneumonia	Until weaning of ventilator or 1 year
Secondary	Bacteria prevalence of ventilator acquired pneumonia		Until weaning of ventilator or 1 year
Secondary	prevalence of diagnostic devices used to identify ventilator acquired pneumonia		Until weaning of ventilator or 1 year