A Platform Trial for Gram Negative Bloodstream Infections

Recruiting now · Not applicable

Conditions studied: Gram-negative Bacteremia

In brief

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.

Key facts

Study ID

NCT06537609

Run by

Sunnybrook Health Sciences Centre

People needed

2500

Starts

2024-04-24

Expected to finish

2028-04-01

Last updated by the study team

2026-02-10

Who can join

Age: any, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• included in BALANCE+ platform

You may not qualify if…

• receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
• arbapenem-non-susceptible
• no de-escalation option due to any or all of:
• antimicrobial resistance
• allergies
• medical contraindications
• drug-drug interaction risk
• other relevant reason
• patients with a suspected or proven polymicrobial source of infection
• > 24 hours since index blood culture susceptibility results finalization
• Beta-lactam versus non-beta-lactam oral/enteral treatment domain
• Inclusion Criteria
• included in BALANCE+ platform
• initially treated with intravenous antibiotics, but clinical team transitioning patient to oral/enteral antibiotic within 7 days of starting treatment
• Exclusion Criteria
• enrolled in an arm of another BALANCE+ platform domain which limits the use of oral/enteral therapy:
• no-de-escalation arm (patients in the no de-escalation arm cannot be randomized into this domain unless they are ready for discharge home, in which case de-escalation is allowable to oral agents at discharge)
• no non-beta-lactam options due to any or all of:
• resistance
• allergies
• medical contraindications
• drug-interaction risk
• other relevant reason
• no beta-lactam options due to any or all of:
• resistance

Where it is running

• Middlemore Hospital — Auckland, Auckland, New Zealand (enrolling)
• John Hunter Hospital — New Lambton, New South Wales, Australia (enrolling)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (enrolling)
• Redcliffe Hospital — Redcliffe, Queensland, Australia (enrolling)
• Sunshine Coast University Hospital — Sunshine Coast, Queensland, Australia (enrolling)
• Monash Medical Center — Clayton, Victoria, Australia (enrolling)
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
• St John of God — Murdoch, Western Australia, Australia (enrolling)
• Foothills Hospital — Calgary, Alberta, Canada (enrolling)
• Peter Lougheed Centre — Calgary, Alberta, Canada (enrolling)
• Rockyview General Hospital — Calgary, Alberta, Canada (enrolling)
• South Health Campus — Calgary, Alberta, Canada (enrolling)
• University of Alberta — Edmonton, Alberta, Canada (enrolling)
• Surrey Memorial Hospital — Surrey, British Columbia, Canada (enrolling)
• Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
• Grace Hospital — Winnipeg, Manitoba, Canada (enrolling)
• Health Sciences Centre — Winnipeg, Manitoba, Canada (enrolling)
• St. Boniface Hospital — Winnipeg, Manitoba, Canada (enrolling)
• Dr. Everett Chalmers Regional Hospital — Fredericton, New Brunswick, Canada (enrolling)
• Eastern Regional Health Authority — St. John's, Newfoundland and Labrador, Canada (enrolling)
• St George Hospital — Kogarah, New South Wales, Australia (enrolling)
• Humber River Health system — North York, Ontario, Canada (enrolling)
• North York General Hospital — North York, Ontario, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Niagara Health System — St. Catharines, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.