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New treatment option for Gram-negative Bacteremia
Official title A Platform Trial for Gram Negative Bloodstream Infections
ClinicalTrials.gov ID: NCT06537609
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 130
You may be able to join if
- PLATFORM Platform
- admitted to a participating hospital
- positive blood culture with Gram negative (GN) bacterium Platform
You likely can't join if
- 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
See the full eligibility criteria
- PLATFORM Platform
- admitted to a participating hospital
- positive blood culture with Gram negative (GN) bacterium Platform
- 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 assigned by chance 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kogarah, New South Wales, Australia
- New Lambton, New South Wales, Australia
- Herston, Queensland, Australia
- Redcliffe, Queensland, Australia
- Sunshine Coast, Queensland, Australia
- Clayton, Victoria, Australia
- Murdoch, Western Australia, Australia
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Fredericton, New Brunswick, Canada
- St. John's, Newfoundland and Labrador, Canada
- Mississauga, Ontario, Canada
- North York, Ontario, Canada
- Ottawa, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
- Laval, Quebec, Canada
+ 6 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kogarah, New South Wales, Australia; New Lambton, New South Wales, Australia; Herston, Queensland, Australia; Redcliffe, Queensland, Australia; Sunshine Coast, Queensland, Australia; Clayton, Victoria, Australia and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.