Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT) (PROACT)
Ventilator Associated Pneumonia
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring Ventilator Associated Pneumonia, Traumatic Brain Injury, stroke, probiotics, VAP, TBI
Eligibility Criteria
Inclusion Criteria: 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 written informed consent provided by the patient or legal representative Exclusion Criteria: 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 those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2) previous transplantation at any time malignancy requiring chemotherapy in the last 3 months neutropenia [absolute neutrophil count < 500]) patients with a primary diagnosis of severe pancreatitis (Ranson score of 3 or more). Mild and moderate pancreatis is not excluded ischemic bowel disease oropharyngeal mucosal injury inability to receive enteral medications intent to withdraw advanced life support as per ICU doctor in charge patients at risk of endovascular infection which includes previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material [mechanical or bioprosthetic cardiac valves] previous or current endocarditis permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids] inferior vena cava filters, dialysis vascular grafts tunnelled (not short-term) hemodialysis catheters pacemakers or defibrillators Patients with peripherally inserted central catheters (PICCs), temporary central venous catheters, central venous dialysis catheters, coronary artery stents, coronary artery bypass grafts (CABG), or neurovascular coils are not excluded, nor are patients with mitral valve prolapse or bicuspid aortic valve if they do not meet any other exclusion criteria. patients with sepsis and/or septic shock
Sites / Locations
- Regional General Hospital F. Miulli
- Intensive Care Unit, Policlinico di Bari
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Interventional: Probiotics
Control: Placebo
Patients will receive a four probiotic preparation (LactoLevure, UniPharma, Athens, Greece).) in capsules containing: Lactobacillus acidophilus LA-5 [1.75 × 109 colony-forming units (cfu)], Lactobacillus plantarum (0.5 × 109 cfu), Bifidobacterium lactis BB12 (1.75 × 109 cfu) and Saccharomyces boulardii (1.5 × 109 cfu).
Patients will receive a placebo in capsules containing powdered glucose polymer.