Status:
RECRUITING
A Platform Trial for Gram Negative Bloodstream Infections
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Gram-negative Bacteremia
Eligibility:
All Genders
Up to 130 years
Phase:
NA
Brief 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...
Detailed Description
BALANCE+ is an adaptive platform trial evaluating multiple treatment options in patients admitted to the hospital due to Gram negative bloodstream infections (BSIs). It focuses on both cross-cutting a...
Eligibility Criteria
Inclusion
- PLATFORM INCLUSION CRITERIA
- Platform
- admitted to a participating hospital
- positive blood culture with Gram negative (GN) bacterium
- Platform
Exclusion
- patient's goals of care are for palliation with no active treatment
- moribund patient, not expected to survive \> 72 hours
- previously enrolled in the platform trial
- not eligible for any domain at the time of screening
- DOMAIN SPECIFIC INCLUSION AND EXCLUSION CRITERIA
- De-escalation versus no de-escalation domain
- Inclusion Criteria
- \- included in BALANCE+ platform
- Exclusion Criteria
- 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
- allergies
- medical contraindications
- drug-interaction risk
- other relevant reason
- pregnancy
- already received \>24 hours of oral antibiotics after index blood culture finalization
- Central vascular catheter replacement domain
- Inclusion Criteria
- included in BALANCE+ platform
- has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)
- Exclusion Criteria
- patient has no ongoing need for a central vascular catheter
- patient has definite indication for central vascular catheter removal
- ongoing septic shock with definite/probable line source
- concomitant S. aureus bacteremia
- concomitant candidemia
- local suppurative signs (severe redness, warmth, pain, swelling or fluctuance/collection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging/echocardiographic findings)
- Low-risk AmpC domain
- Inclusion Criteria
- included in BALANCE+ platform
- positive blood culture with GN bacterium, of the following species: i. Serratia spp. ii Morganella spp. iii Providencia spp. iv Proteus spp. other than P.mirabilis
- organism is susceptible to ceftriaxone
- Exclusion Criteria
- severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS)
- baseline phenotypic non-susceptiblity to ceftriaxone
- more than 1 calendar day beyond availability of susceptibility results
- Follow up blood culture domain
- Inclusion Criteria
- \- included in BALANCE+ platform
- Exclusion Criteria
- patient died or discharged from hospital prior to day 4
- blood culture already collected by the treating team at day 4±1
- \>5 days since index positive blood culture collection
- definite indication for repeat blood culture testing
- concomitant S. aureus bacteremia
- concomitant Candidemia
- clinical suspicion for infective endocarditis
Key Trial Info
Start Date :
April 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06537609
Start Date
April 24 2024
End Date
April 1 2028
Last Update
September 2 2025
Active Locations (36)
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1
St George Hospital
Kogarah, New South Wales, Australia, 2217
2
John Hunter Hospital
New Lambton, New South Wales, Australia
3
Redcliffe Hospital
Redcliffe, Queensland, Australia
4
Sunshine Coast University Hospital
Sunshine Coast, Queensland, Australia