NCT06537609 A Platform Trial for Gram Negative Bloodstream Infections
| NCT ID | NCT06537609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Gram-negative Bacteremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2024-04-24 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
PLATFORM INCLUSION CRITERIA Platform Inclusion Criteria: * admitted to a participating hospital * positive blood culture with Gram negative (GN) bacterium Platform Exclusion Criteria: * 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 1. 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 2. 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 3. 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) 4. 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 5. 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
Contact & Investigator
Nick Daneman, MD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT06537609 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 130 Years, studying Gram-negative Bacteremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06537609 currently recruiting?
Yes, NCT06537609 is actively recruiting participants. Contact the research team at nick.daneman@sunnybrook.ca for enrollment information.
Where is the NCT06537609 trial being conducted?
This trial is being conducted at Kogarah, Australia, New Lambton, Australia, Herston, Australia, Redcliffe, Australia and 11 additional locations.
Who is sponsoring the NCT06537609 clinical trial?
NCT06537609 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Nick Daneman, MD at Sunnybrook Health Sciences Centre. The trial plans to enroll 2,500 participants.