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Grant: Project Grant

Sunnybrook Research Institute (Toronto, Ontario)

$531,675.00

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): A Randomized Controlled Clinical Trial

FY 2020-21

Summary
Bloodstream infections (BSI) are a common and serious problem, affecting 15% of seriously ill patients, increasing length of stay in hospital and doubling mortality. Antibiotic overuse is also a serious problem: 30-50% of antibiotic use is unnecessary or inappropriate and results in avoidable side effects, C. difficile infection, costs, and spiralling antibiotic resistance. The greatest contributor to overuse is excessive treatment durations. Shorter antibiotic treatment (<= 7 days) is as effective as longer treatment for infectious diseases such as bladder infections and pneumonia, but this question has not been studied for hospitalized patients with BSI. Our team's systematic review of the medical literature, national survey, multicentre retrospective study and pilot trial, all supported the need for and feasibility of a randomized controlled trial comparing shorter (7 days) versus longer (14 days) antibiotic treatment for BSI. With a CIHR 2016 Project Grant, we launched the main BALANCE trial to determine whether 7 days of treatment is associated with non-inferior survival rates as compared to 14 days. We have leveraged CIHR's investment with Australian and New Zealand grants and successfully enrolled 1477 patients of the target 3626. We are due to finish on-time and on budget by our original proposal which was endorsed by CIHR as the appropriate mechanism to answer the questions posed. We have demonstrated the ability to engage the international community across 6 countries and 56 centres, have recruited at our target rate, and propose that this "finishing grant" is an excellent return on the original investment. By defining the duration of treatment for BSI, BALANCE will help maximize the clinical cure of individual patients, while minimizing their risk of drug side effects, C. difficile, and antibiotic resistance.
Program
Project Grant
Location
Ontario, Canada
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
448738
Name
Daneman Nick
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): A Randomized Controlled Clinical Trial
Programtype2
Operating Grants
Orgnameinp2
Sunnybrook Research Institute (Toronto, Ontario)
Cihramount2
$531,675
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Antibiotic Treatment; Bacteremia; Critical Care / Intensive Care; Duration Of Therapy; Randomized Controlled Trial
Abstract
Bloodstream infections (BSI) are a common and serious problem, affecting 15% of seriously ill patients, increasing length of stay in hospital and doubling mortality. Antibiotic overuse is also a serious problem: 30-50% of antibiotic use is unnecessary or inappropriate and results in avoidable side effects, C. difficile infection, costs, and spiralling antibiotic resistance. The greatest contributor to overuse is excessive treatment durations. Shorter antibiotic treatment (<= 7 days) is as effective as longer treatment for infectious diseases such as bladder infections and pneumonia, but this question has not been studied for hospitalized patients with BSI. Our team's systematic review of the medical literature, national survey, multicentre retrospective study and pilot trial, all supported the need for and feasibility of a randomized controlled trial comparing shorter (7 days) versus longer (14 days) antibiotic treatment for BSI. With a CIHR 2016 Project Grant, we launched the main BALANCE trial to determine whether 7 days of treatment is associated with non-inferior survival rates as compared to 14 days. We have leveraged CIHR's investment with Australian and New Zealand grants and successfully enrolled 1477 patients of the target 3626. We are due to finish on-time and on budget by our original proposal which was endorsed by CIHR as the appropriate mechanism to answer the questions posed. We have demonstrated the ability to engage the international community across 6 countries and 56 centres, have recruited at our target rate, and propose that this "finishing grant" is an excellent return on the original investment. By defining the duration of treatment for BSI, BALANCE will help maximize the clinical cure of individual patients, while minimizing their risk of drug side effects, C. difficile, and antibiotic resistance.
Competitiondate
202006
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Daneman, Nick; Fowler, Robert A
Approvedterm
2 ans 0 mois
Cihrcontribution2
~ $531,675~ $0~