Clinical trial NCT02585180: Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia
Official title: Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-associated Pneumonia
Keywords: Ventilator-associated pneumonia
Surveillance
Subglottic-secretions
Critically ill patients
Prevention
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: University Hospital, Tours
First posted: 2015-10-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.

This ancillary study will be performed in 14 centers participating to the DEMETER study


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
* Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage will be available during the SSD period of the trial
* Information delivered

Exclusion Criteria:

* Previous inclusion in the study
* Patients moribund at the Intensive Care Unit admission
* Pregnant, parturient or breast-feeding woman
* Patient hospitalized without consent and/or deprived of liberty by court's decision
* Patient under guardianship or curators
* Lack of social insurance
* Concomitant inclusion in a trial on VAP prevention
* Patient with no comprehension of the French language

Primary outcomes:
measure: Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
Secondary outcomes:
measure: Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
Other outcomes:
Locations:
city: Montigny-le-Tilleul.
country: Belgium
facility: CHU André Vésale
city: Annecy
country: France
facility: CH Annecy Genevois
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Beaumont-sur-Oise
country: France
facility: Centre Hospitalier Intercommunal des Portes de l'Oise
city: La roche sur yon
country: France
facility: Chd Vendee
city: Lens
country: France
facility: CH Docteur Schaffner
city: Montauban
country: France
facility: CH de Montauban
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Pointe-à-Pitre
country: France
facility: CHU Pointe à Pitre les Abymes
city: Poissy
country: France
facility: CHI Poissy Saint Germain
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Saint Nazaire
country: France
facility: CH de Saint Nazaire
city: Saint-Denis (Réunion)
country: France
facility: CHU La Réunion, site de Saint Denis de la Réunion
city: Strasbourg
country: France
facility: CHU de Strasbourg Nouvel Hôpital Civil
city: Tours
country: France
facility: CHU Tours, site Bretonneau
Study officials:
affiliation: CHD VENDEE
name: Jean-Claude LACHERADE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28.