A Platform Trial for Gram Negative Bloodstream Infections
Trial Parameters
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