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Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)

Primary Purpose

Ventilator Associated Pneumonia, Infections, C-Difficile

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
L. rhamnosus GG - Probiotic
Placebo - Microcrystalline Cellulose
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lactobacillus rhamnosus GG

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
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
Defined Daily Dose Antibiotic Exposure
Defined daily dose (DDD), daily doses of therapy (DOT), and antibiotic-free days in ICU
Duration of mechanical ventilation
Endotracheal tube or tracheostomy, length of ICU stay and length of hospital stay: recorded as number of days
ICU mortality and in-hospital mortality:
ICU mortality and in-hospital mortality recorded at ICU discharge and hospital discharge.

Full Information

First Posted
June 2, 2015
Last Updated
December 15, 2020
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02462590
Brief Title
Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial
Acronym
PROSPECT
Official Title
Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
November 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Background:Probiotics are live microorganisms thought to have health benefits when ingested. Randomized controlled trials (RCTs) have documented favourable impact on a range of clinical problems, including prevention of upper respiratory tract infections, antibiotic-associated diarrhea, Clostridium difficile-associated diarrhea, and irritable bowel syndrome. Our recent meta-analysis of probiotic RCTs in the intensive care unit (ICU) also suggests 25% lower rates of ventilator-associated pneumonia (VAP) and 18% lower infection rates overall when administered to critically ill mechanically ventilated patients. However, these estimates arise from small, modest quality single-center RCTs yielding imprecise estimates of effect and uncertain generalizability, and require confirmation in a large methodologically rigourous RCT. Before launching a complex costly RCT testing whether probiotics confer benefit, harm, or have no impact on infectious and non-infectious outcomes, a pilot trial was needed. The investigators completed a multicenter pilot RCT for which the primary outcomes relate to feasibility: 1) recruitment success in 1 year; 2) >90% adherence to the probiotic protocol; 3) <5% contamination; 4) an estimated VAP rate. Patients have been randomized in 14 centers in Canada and the US, with an informed consent rate of 84%. 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 will be an internal Pilot which will be incorporated into the main trial. Setting: 13 ICUs in Canada, 2 ICUs in United States Methods: Patients age 18 years or older, admitted to the ICU, with an anticipated duration of ventilation of ≥72 hours are included. Patients are excluded if they have increased risk of iatrogenic probiotic infection or endovascular infection, primary diagnosis of severe acute pancreatitis, percutaneous gastric or jejunal feeding tubes already in situe, strict contraindication or inability to receive enteral medications, have hopeless prognosis, withholding or withdrawal of advanced life support is planned, or if previous enrolment in this or a related trial. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed allocation ratio of 1:1, stratified by ICU and medical/surgical/trauma status. Twice daily, patients receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule or an identical placebo capsule. Both are suspended in water administered via nasogastric tube or by capsule. Research Nurses notify local Study Pharmacists after obtaining informed consent. Study Pharmacists obtain the allocation from the PROSPECT website. Only the Database Manager and Study Pharmacists will have access to the randomization schedule; everyone else remains blinded. Patients receive the intervention until:1) ICU discharge; 2) death; or 3) isolation of Lactobacillus spp. in a sterile site, or if cultured as the sole or predominant organism from a non-sterile site. RCT Trial Outcomes: The primary outcome is VAP; secondary outcomes include ICU-acquired infections, diarrhea (total, antibiotic-associated and CDAD), antibiotic use, length of stay and mortality in the ICU and hospital, and acquired L. rhamnosus GG infections. Relevance: Despite clinical uptake of some existing VAP prevention strategies, the morbidity, mortality and cost of VAP underscore the need for further cost-effective interventions to reduce its impact. Whether probiotics impact on VAP, other infections such as CDAD, antibiotic-associated diarrhea or antibiotic use is unclear. When rigorously evaluated, probiotics may have salutary effects decreasing nosocomial infections as prior RCTs suggest; alternatively, probiotics may have no demonstrable effect, or actually cause infections in critically ill patients with impaired immune function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Infections, C-Difficile, Antibiotic-associated Diarrhea, Diarrhea
Keywords
Probiotics, Ventilator Associated Pneumonia, Infections, C-Difficile, Antibiotic-associated Diarrhea, Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus rhamnosus GG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
L. rhamnosus GG - Probiotic
Other Intervention Name(s)
Culturelle Probiotic
Intervention Description
Twice daily, patients will receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule or an identical placebo capsule
Intervention Type
Drug
Intervention Name(s)
Placebo - Microcrystalline Cellulose
Other Intervention Name(s)
Placebo
Intervention Description
Microcrystalline Cellulose
Primary Outcome Measure Information:
Title
Number of patients with Ventilator Associated Pneumonia (VAP)
Description
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.
Time Frame
60 Days
Secondary Outcome Measure Information:
Title
Number of patients with infections acquired during the ICU stay
Description
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.
Time Frame
60 Days
Title
Number of patients with Clostridium Difficile-associated diarrhea
Description
3 or more episodes of unformed stools in ≤24 hours and C. difficile toxin positive stool or colonoscopic or histopathologic findings demonstrating pseudomembranous colitis
Time Frame
60 Days
Title
Number of patients with antibiotic-associated diarrhea
Description
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
Time Frame
60 Days
Title
Number of patients with diarrhea
Description
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
Time Frame
60 Days
Title
Defined Daily Dose Antibiotic Exposure
Description
Defined daily dose (DDD), daily doses of therapy (DOT), and antibiotic-free days in ICU
Time Frame
60 Days
Title
Duration of mechanical ventilation
Description
Endotracheal tube or tracheostomy, length of ICU stay and length of hospital stay: recorded as number of days
Time Frame
60 Days
Title
ICU mortality and in-hospital mortality:
Description
ICU mortality and in-hospital mortality recorded at ICU discharge and hospital discharge.
Time Frame
60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah J Cook, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Peter Louheed Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Univeristy of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Royal Columbia Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Vancouver Island Health Authority
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Health Science - Winnipeg
City
Winnipeg
State/Province
Manatoba
ZIP/Postal Code
R3E 0M1
Country
Canada
Facility Name
St. Boniface
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
QEII
City
Halfax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
William Osler Brampton - Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Brantford General Hospital
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 1G9
Country
Canada
Facility Name
Joseph Brant Hospital
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7S 1W7
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Ontario
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Hamilton Health Science Centre - Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hamilton Health Science Centre - Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
LHSC - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Ottawa Civic Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Niagara Health - St. Catharine's Hospital
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
UHN - Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
St. Joseph's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hôtel-Dieu de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Center Hospital University Montreal (NCHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Sacre Coeur Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Center Hospital University Montreal (CHUM) - Notre Dame
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L M1
Country
Canada
Facility Name
Center Hospital University (CHUM) - Saint Luc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 1R9
Country
Canada
Facility Name
Hôpital de l'Enfant-Jesus, CHU de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Sherbrooke Hospital
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
King Adulaziz Medical Center
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35724443
Citation
Takaoka A, Zytaruk N, Davis M, Matte A, Johnstone J, Lauzier F, Marshall J, Adhikari N, Clarke FJ, Rochwerg B, Lamontagne F, Hand L, Watpool I, Porteous RK, Masse MH, D'Aragon F, Niven D, Heels-Ansdell D, Duan E, Dionne J, English S, St-Arnaud C, Millen T, Cook DJ; PROSPECT Investigators and the Canadian Critical Care Trials Group. Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study. J Crit Care. 2022 Oct;71:154094. doi: 10.1016/j.jcrc.2022.154094. Epub 2022 Jun 17.
Results Reference
derived
PubMed Identifier
34546300
Citation
Johnstone J, Meade M, Lauzier F, Marshall J, Duan E, Dionne J, Arabi YM, Heels-Ansdell D, Thabane L, Lamarche D, Surette M, Zytaruk N, Mehta S, Dodek P, McIntyre L, English S, Rochwerg B, Karachi T, Henderson W, Wood G, Ovakim D, Herridge M, Granton J, Wilcox ME, Goffi A, Stelfox HT, Niven D, Muscedere J, Lamontagne F, D'Aragon F, St-Arnaud C, Ball I, Nagpal D, Girard M, Aslanian P, Charbonney E, Williamson D, Sligl W, Friedrich J, Adhikari NK, Marquis F, Archambault P, Khwaja K, Kristof A, Kutsogiannis J, Zarychanski R, Paunovic B, Reeve B, Lellouche F, Hosek P, Tsang J, Binnie A, Trop S, Loubani O, Hall R, Cirone R, Reynolds S, Lysecki P, Golan E, Cartin-Ceba R, Taylor R, Cook D; Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) Investigators and the Canadian Critical Care Trials Group. Effect of Probiotics on Incident Ventilator-Associated Pneumonia in Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1024-1033. doi: 10.1001/jama.2021.13355.
Results Reference
derived
PubMed Identifier
31227528
Citation
Johnstone J, Heels-Ansdell D, Thabane L, Meade M, Marshall J, Lauzier F, Duan EH, Zytaruk N, Lamarche D, Surette M, Cook DJ; PROSPECT Investigators and the Canadian Critical Care Trials Group. Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT. BMJ Open. 2019 Jun 20;9(6):e025228. doi: 10.1136/bmjopen-2018-025228.
Results Reference
derived

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Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial

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