Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)
Ventilator Associated Pneumonia, Infections, C-Difficile
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring Probiotics, Ventilator Associated Pneumonia, Infections, C-Difficile, Antibiotic-associated Diarrhea, Diarrhea
Eligibility Criteria
Inclusion Criteria:
- Adults ≥ 18 years of age
- Admitted to any ICU and receiving invasive mechanical ventilation
- Anticipated ventilation of ≥72 hours at the time of screening, as per the ICU physician.
Exclusion Criteria:
- Invasively mechanically ventilated >72 hours at the time of screening;
- Patients at potential increased risk of iatrogenic probiotic infection (see Section 2.6 for detailed explanation) including specific immunocompromised populations (HIV <200 CD4 cells/μL, those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2), previous transplantation (including stem cell) at any time, malignancy requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count < 500]). However, patients receiving corticosteroids previously or presently or projected to receive corticosteroids are not excluded;
- Patients at risk for endovascular infection (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 bio-prosthetic 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 temporary central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs) are not excluded and patients with coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded; patients with mitral valve prolapse or bicuspid aortic valve are not excluded providing they have no other exclusion criteria;
- Patients with a primary diagnosis of severe acute pancreatitis, without reference to a Ranson score [Ranson 1974]). However, patients with mild or moderate pancreatitis are not excluded;
- Patients with percutaneous gastric or jejunal feeding tubes already in situ as per Health Canada guidance;
- Strict contraindication or inability to receive enteral medications;
- Intent to withdraw advanced life support as per the ICU physician;
- Previous enrolment in this or current enrolment in a potentially confounding tria
Sites / Locations
- Mayo Clinic
- St. John's Mercy Medical Center
- Peter Louheed Center
- Foothills Medical Center
- Univeristy of Alberta
- Royal Columbia Hospital
- Vancouver General Hospital
- St. Paul's Hospital
- Vancouver Island Health Authority
- Health Science - Winnipeg
- St. Boniface
- QEII
- William Osler Brampton - Brampton Civic Hospital
- Brantford General Hospital
- Joseph Brant Hospital
- Royal Alexandra Hospital
- Hamilton Health Science Centre - Hamilton General Hospital
- St Joseph's Healthcare Hamilton
- Hamilton Health Science Centre - Juravinski Hospital
- Kingston General Hospital
- Grand River Hospital
- LHSC - University Hospital
- LHSC - Victoria Hospital
- Ottawa General Hospital
- Ottawa Civic Hospital
- Niagara Health - St. Catharine's Hospital
- Sunnybrook Health Sciences Centre
- St. Michael's Hospital
- Mount Sinai Hospital
- Toronto General Hospital
- UHN - Toronto Western Hospital
- St. Joseph's Hospital
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
- Hôtel-Dieu de Lévis
- Center Hospital University Montreal (NCHUM)
- Montreal General Hospital
- Royal Victoria Hospital
- Sacre Coeur Hospital
- Hôpital Maisonneuve-Rosemont
- Center Hospital University Montreal (CHUM) - Notre Dame
- Center Hospital University (CHUM) - Saint Luc
- Hôpital de l'Enfant-Jesus, CHU de Quebec
- Sherbrooke Hospital
- King Adulaziz Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Lactobacillus rhamnosus GG
Placebo
Patients allocated to the intervention group will receive 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule suspended in tap water, administered through a nasogastric (or orogastric) or nasoduodenal (or oroduodenal) tube twice daily while patients are in the ICU. The first dose will be within 72 hours of intubation. Patients in the ICU who await discharge and can swallow pills will take the capsules orally.
Patients allocated to the placebo group will receive a capsule identical in appearance to the L. rhamnosus GG capsule, but containing microcrystalline cellulose. The placebo will also be suspended in tap water and similarly administered twice a day. When suspended in water, the placebo has identical appearance and consistency as the probiotic. The placebo will be prepared by the manufacturer of L. rhamnosus GG, Culturelle, and has been used successfully in a recent RCT in the ICU population [Morrow 2010]. This has also been used successfully in the PROSPECT Pilot Trial.