ArticleBMJ open2025
Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05893147 (BALANCE+), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections
Who cites it
3 citing papers in PubMed.
- Managing multidrug resistant Gram-negative bacteraemia in immunocompromised hosts.Current opinion in infectious diseases · 2026Review
- Article
- Seven versus fourteen days for resistant bloodstream infections: what do we actually know? A scoping review.Infection · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesGram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.
designAdaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.
settingTen hospitals across four Canadian provinces.
participantsIndividuals admitted to hospital with blood cultures yielding Gram negative bacteria.
interventionsThe five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms. PRIMARY OUTCOME MEASURES: Domain-specific recruitment rates and protocol adherence.
resultsDuring the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).
conclusionsThe vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications. TRIAL REGISTRATION NUMBER: NCT05893147.
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