Pneumonia, Ventilator-AssociatedINCIPAVENCT03105414
INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children
An observational study of Pneumonia, Ventilator-Associated, run by Sylvie Chevret at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 2,100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2017to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients admitted to Pediatric Intensive Care Unit 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.
Who may be able to join
- Admitted to Pediatric Intensive Care Unit
- Aged more than 28 days and < 18 years
- Mechanically ventilated either by endotracheal or tracheostomy tube
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Robert Debré Hospital
Paris, 75019
Stéphane Dauger, MD, 1 40 03 21 87 ext. +33, stephane.dauger@aphp.fr
About this study
Official title: Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant
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.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Mechanical ventilation
- Keywords
- Mechanical ventilation, Pediatrics, Cross infection, Intensive care, Diagnosis
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Mechanical ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator acquired pneumonia
CDC definition of ventilator acquired pneumonia
Measured: Until weaning of ventilator or 1 year
Secondary outcomes (2)
Bacteria prevalence of ventilator acquired pneumonia
Measured: Until weaning of ventilator or 1 year
prevalence of diagnostic devices used to identify ventilator acquired pneumonia
Measured: Until weaning of ventilator or 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start3 Apr 2017
- Primary completion15 May 2018 (estimated)
- Study completion15 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sylvie Chevret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvie Chevret, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105414
- Sponsor's protocol ID
- 11-362
- Acronym
- INCIPAVE
- Status last verified
- May 2017
- First submitted
- 4 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant
- ClinicalTrials.gov ID
- NCT03105414
- Acronym / sponsor ID
- INCIPAVE / 11-362
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Mechanical ventilation, Pediatrics, Cross infection, Intensive care, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Sylvie ChevretUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 15 May 2018 (estimated)
- Study completion
- 15 May 2019 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients admitted to Pediatric Intensive Care Unit 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.
Key inclusion criteria (3 listed)
- Admitted to Pediatric Intensive Care Unit
- Aged more than 28 days and < 18 years
- Mechanically ventilated either by endotracheal or tracheostomy tube
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationMechanical ventilation | Device | – |
Primary outcome
Incidence of ventilator acquired pneumonia
Time frame: Until weaning of ventilator or 1 year
CDC definition of ventilator acquired pneumonia
2 secondary outcomes
Bacteria prevalence of ventilator acquired pneumonia
Time frame: Until weaning of ventilator or 1 year
prevalence of diagnostic devices used to identify ventilator acquired pneumonia
Time frame: Until weaning of ventilator or 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumonia, Ventilator-Associated
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated, run by Sylvie Chevret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Dauger, MD (140032000 ext. +33, stephane.dauger@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator acquired pneumonia (time frame: Until weaning of ventilator or 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.