Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

Prior treatment

• has received mechanical ventilation more than 72 hours from start of screening
• those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2)
• previous transplantation at any time
• inability to receive enteral medications
• 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.

Other illness

• patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes
• HIV \<200 CD4 cells/μL
• malignancy requiring chemotherapy in the last 3 months
• ischemic bowel disease

Lab values

• neutropenia \[absolute neutrophil count \< 500\])

Other

• pregnancy or Lactation
• patients with a primary diagnosis of severe pancreatitis (Ranson score of 3 or more). Mild and moderate pancreatis is not excluded
• oropharyngeal mucosal injury
• intent to withdraw advanced life support as per ICU doctor in charge
• patients with sepsis and/or septic shock

• 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