Grant: Operating Grant: Clinical Trials Projects
University of Manitoba
$5,500,001.00
Dexamethasone For Preventing Deterioration In Community Acquired Pneumonia (DEFEND-CAP)
EF 2023-24
Résumé
Pneumonia is an infection of the lungs and is one of the most common cause for hospitalization in the world. Those infected with pneumonia can develop breathing failure, need for life support and have a high risk of death. Poor outcomes from pneumonia are driven by inflammation which causes the body's organs to malfunction. Preliminary studies in pneumonia caused by COVID-19, and other pathogens have shown that treatment with steroids, a commonly used anti-inflammatory medication, safely reduces organ failure, and improves survival in patients hospitalized for pneumonia. The studies, however, have shown mixed results, leaving doctors and policy makers uncertain of which patients with pneumonia will benefit steroids. The goal of this clinical trial is to establish whether steroids can reduce critical illness (admission to ICU) and increase survival in patients hospitalized for pneumonia. This study will compare patients who are treated with dexamethasone to those that receive a placebo. The study will measure whether a patient becomes critically ill and requires life support, or dies. It will also monitor patients for other important outcomes such as new infections, high blood sugars, and stomach bleeding). This trial uses an innovative design that allows the trial to learn as it proceeds, observing where steroids are working and where they are not. This knowledge gained from patients enrolled will influence how we treat pneumonia in Canda and around the world. The trial answers a pressing health priority, but also serves to better prepare Canada for future pandemics or health emergencies by establishing a robust network of hospitals with experience enrolling non-critically ill (ie. hospital wards) into platform trials. The trial leverages investments made by CIHR to study an inexpensive, widely available drug and creates opportunities that will be further used by Canada's biomanufacturing industry to test novel future therapies or diagnostic platforms.
Programme
Operating Grant: Clinical Trials Projects
Bénéficiaire
Emplacement
Manitoba, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
497335
Name
Zarychanski Ryan
Region
Manitoba
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Clinical Trials Projects - Full Application
Projecttitle
Dexamethasone For Preventing Deterioration In Community Acquired Pneumonia (DEFEND-CAP)
Programtype2
Operating Grants
Orgnameinp2
University of Manitoba
Cihramount2
$5,500,001
Cihrequipment2
$0
Programname2
Operating Grant: Clinical Trials Projects
Keyworddelim
Bayesian Adaptive Trial; Community Acquired Pneumonia (Cap); Corticosteroids; Dexamethasone; Phase Iii Trial; Randomized Trial
Abstract
Pneumonia is an infection of the lungs and is one of the most common cause for hospitalization in the world. Those infected with pneumonia can develop breathing failure, need for life support and have a high risk of death. Poor outcomes from pneumonia are driven by inflammation which causes the body's organs to malfunction. Preliminary studies in pneumonia caused by COVID-19, and other pathogens have shown that treatment with steroids, a commonly used anti-inflammatory medication, safely reduces organ failure, and improves survival in patients hospitalized for pneumonia. The studies, however, have shown mixed results, leaving doctors and policy makers uncertain of which patients with pneumonia will benefit steroids. The goal of this clinical trial is to establish whether steroids can reduce critical illness (admission to ICU) and increase survival in patients hospitalized for pneumonia. This study will compare patients who are treated with dexamethasone to those that receive a placebo. The study will measure whether a patient becomes critically ill and requires life support, or dies. It will also monitor patients for other important outcomes such as new infections, high blood sugars, and stomach bleeding). This trial uses an innovative design that allows the trial to learn as it proceeds, observing where steroids are working and where they are not. This knowledge gained from patients enrolled will influence how we treat pneumonia in Canda and around the world. The trial answers a pressing health priority, but also serves to better prepare Canada for future pandemics or health emergencies by establishing a robust network of hospitals with experience enrolling non-critically ill (ie. hospital wards) into platform trials. The trial leverages investments made by CIHR to study an inexpensive, widely available drug and creates opportunities that will be further used by Canada's biomanufacturing industry to test novel future therapies or diagnostic platforms.
Competitiondate
202311
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Zarychanski, Ryan; Lawler, Patrick R; Lother, Sylvain; McDonald, Emily G
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $5,500,001~ $0~