Can we Better Understand the Development of VAP and Eventually Predict and Prevent it?

NCT01875692 | Completed

• 1 other identifier: 12-051
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The hypothesis of the investigators is that during the first days of intubation, independently of the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the selection of one pathogen in the trachea, that will finally be the cause of VAP. The investigators designed a prospective study including 300 patients intubated for more than 3 days, with daily analysis of oro-pharyngeal juice and tracheal aspirate by culture and metagenomics, in order to determine if this microbiological surveillance permits:

1. 1.To predict a high risk to develop a VAP in the next 48h and even to predict its agent
2. 2.To better understand the development of VAP by studying the evolution of the "respiratory flora" in the context of intubation

Conditions

Pneumonia, Ventilator-Associated

Keywords

Metagenomic; Ventilator-Associated Pneumonia (VAP)

Outcome Measures

Primary Outcomes (4)

• Percentage of cases where tracheal (same for oropharyngeal) aspirate clearly showing a selection of the same pathogen retrieved later in the bronchoalveolar lavage (BAL), when VAP happens.

  This will provide the sensitivity of tracheal culture to identify correctly the agent of VAP before VAP happens.

  After 18 months

• Percentage of case where the pathogen selected in tracheal (same for oropharyngeal) aspirate do not correspond to the agent of VAP as identified by BAL.

  Helps to determine the "specificity" of tracheal aspirates to predict the agent of VAP.

  After 18 months

• Percentage of cases where despite the selection of only one pathogen in tracheal aspirate (same for oropharyngeal) aspirate, the patient did never suffer from VAP

  Helps determining the positive and negative predictive values of tracheal aspirates to predict VAP.

  After 18 months

• Presence of Ventilator-Associated-Pneumonia (VAP)

  After 18 month

Secondary Outcomes (3)

• Percentage of VAP in the study population

  After 18 months

• Type of bacteria retrieved on intubation day compared to type of bacteria retrieved after 1 week of intubation

  After 18 months

• Evolution of metagenomics of oropharyngeal - tracheal aspirates in cases (VAP) and control (no VAP)

  After 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU adult patients intubated in the last 24h for a condition that will probably require more than 3 days of mechanical ventilation.

You may qualify if:

• Patient hospitalised in the adult ICU of HUG (\>18 years old)
• Intubated for \< 24 hours
• Expected duration of intubation \> 4 days (e.g. neurologic disease)

You may not qualify if:

• Patients for whom regular tracheal aspirations cannot not be performed (because of unstable intracranial pressure, for example).
• New antibiotic therapy in the week preceding the intubation

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital

Geneva, Canton of Geneva, 1201, Switzerland

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Schrenzel, Prof.

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: June 12, 2013
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CH (1)