Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)
ConditionVentilator Associated Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Bari
About this trial
PROACT study aims to resolve uncertainties to influence actual practice guidelines or public health policing regarding VAP prevention in ICU by using probiotics administration.
Multi-trauma patients with a head injury OR stroke or brain haemorrhage patients without any sign of aspiration and lung infection will be enrolled and randomized to either placebo or probiotic treatment to assess if VAP and mortality can be reduced in the interventional group.
Eligibility criteria
Qualifiers
adults aged 18-80 years
at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage without any sign of aspiration and lung infection
intubation and start of mechanical ventilation. This needs to start immediately after the event described in the inclusion criteria (b). For cases of head trauma this is defined as start in the ambulance or the emergency department
likelihood that the duration of mechanical ventilation would be at least six days
Disqualifiers
has received mechanical ventilation more than 72 hours from start of screening
pregnancy or Lactation
patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes
HIV <200 CD4 cells/μL
Trial design
Treatments tested in this trial
- LactoLevure
- Placebo
Treatment groups
186 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Bari
Lead sponsor
Uni-Pharma
Collaborator
Source ClinicalTrials.gov