Diarrhea Clinical Trial
— PROSPECTOfficial title:
Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)
Verified date | January 2019 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Probiotics are commercially available live bacteria thought to have health benefits when ingested. A literature review of probiotic studies in the intensive care unit (ICU) found that in patients who receive probiotics, there is a 25% reduction in lung infection, known as ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of developing any infection in the ICU. However, the studies reviewed were small and not well done. Therefore, whether probiotics are really helpful or not is unclear. Before a large carefully performed study is done to evaluate the effects of probiotics in critically ill patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing search for more effective strategies to prevent serious infection during critical illness. Probiotics may be an easy-to-use, readily available, inexpensive approach to help future critically ill patients around the world.
Status | Completed |
Enrollment | 2650 |
Est. completion date | November 17, 2020 |
Est. primary completion date | March 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults = 18 years of age 2. Admitted to any ICU and receiving invasive mechanical ventilation 3. Anticipated ventilation of =72 hours at the time of screening, as per the ICU physician. Exclusion Criteria: 1. Invasively mechanically ventilated >72 hours at the time of screening; 2. 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; 3. 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; 4. 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; 5. Patients with percutaneous gastric or jejunal feeding tubes already in situ as per Health Canada guidance; 6. Strict contraindication or inability to receive enteral medications; 7. Intent to withdraw advanced life support as per the ICU physician; 8. Previous enrolment in this or current enrolment in a potentially confounding tria |
Country | Name | City | State |
---|---|---|---|
Canada | William Osler Brampton - Brampton Civic Hospital | Brampton | Ontario |
Canada | Brantford General Hospital | Brantford | Ontario |
Canada | Joseph Brant Hospital | Burlington | Ontario |
Canada | Foothills Medical Center | Calgary | Alberta |
Canada | Peter Louheed Center | Calgary | Alberta |
Canada | Royal Alexandra Hospital | Edmonton | Ontario |
Canada | Univeristy of Alberta | Edmonton | Alberta |
Canada | QEII | Halfax | Nova Scotia |
Canada | Hamilton Health Science Centre - Hamilton General Hospital | Hamilton | Ontario |
Canada | Hamilton Health Science Centre - Juravinski Hospital | Hamilton | Ontario |
Canada | St Joseph's Healthcare Hamilton | Hamilton | Ontario |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | Grand River Hospital | Kitchener | Ontario |
Canada | Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Laval | Quebec |
Canada | Hôtel-Dieu de Lévis | Lévis | Quebec |
Canada | LHSC - University Hospital | London | Ontario |
Canada | LHSC - Victoria Hospital | London | Ontario |
Canada | Center Hospital University Montreal (NCHUM) | Montreal | Quebec |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | Royal Victoria Hospital | Montreal | Quebec |
Canada | Sacre Coeur Hospital | Montreal | Quebec |
Canada | Center Hospital University (CHUM) - Saint Luc | Montréal | Quebec |
Canada | Center Hospital University Montreal (CHUM) - Notre Dame | Montréal | Quebec |
Canada | Hôpital Maisonneuve-Rosemont | Montréal | Quebec |
Canada | Royal Columbia Hospital | New Westminster | British Columbia |
Canada | Ottawa Civic Hospital | Ottawa | Ontario |
Canada | Ottawa General Hospital | Ottawa | Ontario |
Canada | Hôpital de l'Enfant-Jesus, CHU de Quebec | Quebec City | Quebec |
Canada | Sherbrooke Hospital | Sherbrooke | Quebec |
Canada | Niagara Health - St. Catharine's Hospital | St. Catharines | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | St. Joseph's Hospital | Toronto | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | UHN - Toronto Western Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | Vancouver Island Health Authority | Vancouver | British Columbia |
Canada | Health Science - Winnipeg | Winnipeg | Manatoba |
Canada | St. Boniface | Winnipeg | Manitoba |
Saudi Arabia | King Adulaziz Medical Center | Riyadh | |
United States | Mayo Clinic | Rochester | Minnesota |
United States | St. John's Mercy Medical Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
United States, Canada, Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with Ventilator Associated Pneumonia (VAP) | VAP will be diagnosed clinically at each site in patients who are receiving invasive mechanical ventilation for at least 48 hours, when there is a new, progressive or persistent radiographic infiltrate with no other obvious cause and the presence of any 2 of the following symptoms or signs: 1) fever (temperature >38°C) or hypothermia (temperature <36°C as measured by core body temperature); 2) relative neutropenia (<3.0 x 106/L) or leukocytosis (>10 x 106/L) and 3) purulent sputum. | 60 Days | |
Secondary | Number of patients with infections acquired during the ICU stay | Any infection acquired during the ICU stay, defined as respiratory or other infections including bloodstream infections, intravascular catheter-related sepsis, intra-abdominal infections, urosepsis and surgical wound infections. | 60 Days | |
Secondary | Number of patients with Clostridium Difficile-associated diarrhea | 3 or more episodes of unformed stools in =24 hours and C. difficile toxin positive stool or colonoscopic or histopathologic findings demonstrating pseudomembranous colitis | 60 Days | |
Secondary | Number of patients with antibiotic-associated diarrhea | Antibiotic-associated diarrhea and defined as more than 2 liquid stools a day for 3 or more days in quantities in excess of normal for each patient | 60 Days | |
Secondary | Number of patients with diarrhea | Diarrhea defined as 3 or more loose or watery bowel movements, according to the Bristol Stool Chart (type 6 or 7) and use of a fecal management device | 60 Days | |
Secondary | Defined Daily Dose Antibiotic Exposure | Defined daily dose (DDD), daily doses of therapy (DOT), and antibiotic-free days in ICU | 60 Days | |
Secondary | Duration of mechanical ventilation | Endotracheal tube or tracheostomy, length of ICU stay and length of hospital stay: recorded as number of days | 60 Days | |
Secondary | ICU mortality and in-hospital mortality: | ICU mortality and in-hospital mortality recorded at ICU discharge and hospital discharge. | 60 Days |
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