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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03105414
Other study ID # 11-362
Secondary ID
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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