Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Platform Trial for Gram Negative Bloodstream Infections
Sponsor: Sunnybrook Health Sciences Centre
Summary
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.
Official title: BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections
Key Details
Gender
All
Age Range
0 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2024-04-24
Completion Date
2028-04
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
De-escalation VS No De-escalation
No de-escalation group: continue to receive the same antibiotic that was started initially (as long as it is confirmed to be effective based on the blood culture sensitivity result). De-escalation is only allowed within 7 days if patient is being discharged from hospital. De-escalation group: switched to narrower spectrum antibiotic (based on spectrum scale specified in protocol).
Oral beta-lactams VS non beta-lactams
Beta-lactam antibiotic: This can be, but not limited to, amoxicillin, amoxicillin-clavulanate, cephalexin, cefadroxil, or cefixime. Non beta-lactam antibiotic: This can be ciprofloxacin, moxifloxacin, levofloxacin or trimethoprim-sulfamethoxazole.
Central vascular catheter retention VS Central vascular catheter replacement
Central vascular catheter replacement: the catheter will be changed by the treating team as soon as possible and within a maximum of 72 hours from blood culture finalization Central vascular catheter retention: the catheter will not be changed and will be retained until it is non functional or no longer needed.
Cephalosporin VS Carbapenem for low risk AmpC organisms
Cephalosporin (ceftriaxone) at standard doses Carbapenem (Meropenem or Ertapenem) at standard doses
Routine follow-up blood culture VS No routine follow-up blood culture
Routine follow-up blood culture: routine repeat blood collection 4 days from the index blood collection with positive bacteria. No follow-up blood culture: no routine repeat blood collection 4 days from the index blood collection with positive bacteria
Locations (39)
St George Hospital
Kogarah, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Sunshine Coast University Hospital
Sunshine Coast, Queensland, Australia
Monash Medical Center
Clayton, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
St John of God
Murdoch, Western Australia, Australia
Foothills Hospital
Calgary, Alberta, Canada
Peter Lougheed Centre
Calgary, Alberta, Canada
Rockyview General Hospital
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Surrey Memorial Hospital
Surrey, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Grace Hospital
Winnipeg, Manitoba, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, Canada
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada
Trillium Health Partners - Mississauga Hospital
Mississauga, Ontario, Canada
Humber River Health system
North York, Ontario, Canada
North York General Hospital
North York, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Niagara Health System
St. Catharines, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Michael Garron Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
CHU de Québec - Université Laval
Laval, Quebec, Canada
Hôpital de la Cité de la Santé
Laval, Quebec, Canada
Montreal General Hospital- McGill
Montreal, Quebec, Canada
Royal Victoria Hospital- McGill
Montreal, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Centre hospitalier affilié universitaire régional (CHAUR)
Trois-Rivières, Quebec, Canada
Universidad de La Sabana
Chía, Cundinamarca, Colombia
Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Middlemore Hospital
Auckland, Auckland, New Zealand