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Oral beta-lactams VS non beta-lactams / De-escalation VS No De-escalation / Cephalosporin VS Carbapenem for low risk AmpC organisms · Interventional Study
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
BALANCE+ is a perpetual multiple-domain randomized platform trial designed to evaluate competing treatment strategies for gram-negative bloodstream infections, with planned enrollment of 2,500 participants and a composite primary outcome (Desirability of Outcome Ranking) assessed at 90 days. This is a registry record only; no results have been posted, and the trial is currently recruiting.
Interventional, Randomized, Parallel, Open label, Treatment purpose. Gram-negative Bacteremia; age from 0 Years; to 130 Years. Intervention: De-escalation VS No De-escalation; Oral beta-lactams VS Oral Non-beta-lactams; Central vascular catheter retention VS Central vascular cat…; Cephalosporin VS Carbapenem for low risk AmpC organisms; Routine follow-up blood culture VS No rou…. Compared with: No de-escalation; Non-beta-lactams; Central vascular catheter replacement; Carbapenem for low-risk AmpC organisms; No routine follow-up blood culture (evaluated across five randomized domains).. n = 2,500. 39 sites across 5 countries.
BALANCE+ is a perpetual multiple-domain randomized platform trial designed to evaluate competing treatment strategies for gram-negative bloodstream infections, with planned enrollment of 2,500 participants and a composite primary outcome (Desirability of Outcome Ranking) assessed at 90 days. This is a registry record only; no results have been posted, and the trial is currently recruiting.
Trial is actively recruiting; no safety, efficacy, or comparative effectiveness data can be assessed.
The source did not state who this applies to in practice.
This is a registry record for an actively recruiting platform trial with no results posted; it describes planned design and enrollment only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06537609). This is a study registration, not published results. Lead sponsor: Sunnybrook Health Sciences Centre. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 2500 participants (ESTIMATED). Conditions: Gram-negative Bacteremia. Interventions: OTHER: De-escalation VS No De-escalation; OTHER: Oral beta-lactams VS non beta-lactams; OTHER: Central vascular catheter retention VS Central vascular catheter replacement; OTHER: Cephalosporin VS Carbapenem for low risk AmpC organisms; OTHER: Routine follow-up blood culture VS No routine follow-up blood culture. Primary outcome measures: Desirability of Outcome Ranking (DOOR) Ordinal Scale which incorporates death, reinfection, readmission, and for some domains incorporates a tie-breaker of new antimicrobial resistance (AMR). , 90 days. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.