Actively Recruiting
A Platform Trial for Gram Negative Bloodstream Infections
Led by Sunnybrook Health Sciences Centre · Updated on 2026-02-10
2500
Participants Needed
39
Research Sites
205 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance. The initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.
CONDITIONS
Official Title
A Platform Trial for Gram Negative Bloodstream Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to a participating hospital
- Positive blood culture with Gram-negative bacterium
- Included in BALANCE+ platform for each specific domain
- For oral antibiotic domain: initially treated with intravenous antibiotics and transitioning to oral/enteral antibiotics within 7 days
- For central vascular catheter domain: has an indwelling central vascular catheter in place within 48 hours before bloodstream infection onset
- For low-risk AmpC domain: positive blood culture with specific Gram-negative species susceptible to ceftriaxone
- For follow-up blood culture domain: included in BALANCE+ platform
You will not qualify if you...
- Goals of care are for palliation with no active treatment
- Moribund patient not expected to survive more than 72 hours
- Previously enrolled in the platform trial
- Not eligible for any domain at screening
- Receiving empiric antibiotics to which bacteria are not sensitive (de-escalation domain)
- Carbapenem-non-susceptible bacteria (de-escalation domain)
- No de-escalation option due to resistance, allergies, contraindications, or drug interactions (de-escalation domain)
- Suspected or proven polymicrobial infection (de-escalation domain)
- More than 24 hours since blood culture susceptibility results finalized (de-escalation domain)
- Enrolled in other domain arms limiting oral therapy (oral antibiotic domain)
- No beta-lactam or non-beta-lactam oral options due to resistance, allergies, contraindications, or drug interactions (oral antibiotic domain)
- Pregnancy (oral antibiotic domain)
- Received more than 24 hours of oral antibiotics after blood culture finalization (oral antibiotic domain)
- No ongoing need for central vascular catheter (catheter domain)
- Definite indication for catheter removal (catheter domain)
- Ongoing septic shock with probable line source or evidence of infected line (catheter domain)
- Severe allergy to beta-lactams or ceftriaxone non-susceptibility (low-risk AmpC domain)
- More than 1 day beyond availability of susceptibility results (low-risk AmpC domain)
- Patient died or discharged before day 4 (follow-up blood culture domain)
- Blood culture already collected around day 4 (follow-up blood culture domain)
- More than 5 days since index blood culture collection (follow-up blood culture domain)
- Definite indication for repeat blood culture testing such as Staphylococcus aureus bacteremia, candidemia, or suspicion for infective endocarditis (follow-up blood culture domain)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
2
John Hunter Hospital
New Lambton, New South Wales, Australia
Actively Recruiting
3
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
4
Redcliffe Hospital
Redcliffe, Queensland, Australia
Actively Recruiting
5
Sunshine Coast University Hospital
Sunshine Coast, Queensland, Australia
Actively Recruiting
6
Monash Medical Center
Clayton, Victoria, Australia
Actively Recruiting
7
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Actively Recruiting
8
St John of God
Murdoch, Western Australia, Australia
Actively Recruiting
9
Foothills Hospital
Calgary, Alberta, Canada
Actively Recruiting
10
Peter Lougheed Centre
Calgary, Alberta, Canada
Actively Recruiting
11
Rockyview General Hospital
Calgary, Alberta, Canada
Actively Recruiting
12
South Health Campus
Calgary, Alberta, Canada
Actively Recruiting
13
University of Alberta
Edmonton, Alberta, Canada
Actively Recruiting
14
Surrey Memorial Hospital
Surrey, British Columbia, Canada
Actively Recruiting
15
Vancouver General Hospital
Vancouver, British Columbia, Canada
Actively Recruiting
16
Grace Hospital
Winnipeg, Manitoba, Canada
Actively Recruiting
17
Health Sciences Centre
Winnipeg, Manitoba, Canada
Actively Recruiting
18
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Actively Recruiting
19
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, Canada
Actively Recruiting
20
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada
Actively Recruiting
21
Trillium Health Partners - Mississauga Hospital
Mississauga, Ontario, Canada
Not Yet Recruiting
22
Humber River Health system
North York, Ontario, Canada
Actively Recruiting
23
North York General Hospital
North York, Ontario, Canada
Actively Recruiting
24
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
25
Niagara Health System
St. Catharines, Ontario, Canada
Actively Recruiting
26
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
27
Michael Garron Hospital
Toronto, Ontario, Canada
Actively Recruiting
28
Mount Sinai Hospital
Toronto, Ontario, Canada
Actively Recruiting
29
St. Joseph's Health Centre
Toronto, Ontario, Canada
Actively Recruiting
30
University Health Network
Toronto, Ontario, Canada
Actively Recruiting
31
CHU de Québec - Université Laval
Laval, Quebec, Canada
Actively Recruiting
32
Hôpital de la Cité de la Santé
Laval, Quebec, Canada
Actively Recruiting
33
Montreal General Hospital- McGill
Montreal, Quebec, Canada
Actively Recruiting
34
Royal Victoria Hospital- McGill
Montreal, Quebec, Canada
Actively Recruiting
35
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Actively Recruiting
36
Centre hospitalier affilié universitaire régional (CHAUR)
Trois-Rivières, Quebec, Canada, G8Z 3R9
Actively Recruiting
37
Universidad de La Sabana
Chía, Cundinamarca, Colombia
Actively Recruiting
38
Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Actively Recruiting
39
Middlemore Hospital
Auckland, Auckland, New Zealand, 2025
Actively Recruiting
Research Team
N
Nick Daneman, MD
CONTACT
M
Mithun Mohan George
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here