Main Trial Transition

Evidence quality

Highlighted claims

• The vanguard phase confirmed overall feasibility and BALANCE+ transitioned to the full platform trial. — Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+
• The main trial uses Bayesian analyses with non-informative priors and prespecified superiority or futility thresholds. — Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+
• Vanguard patients were included in the main trial because protocol changes were minimal. — Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+
• The catheter and AmpC domains were retained despite low recruitment because no competing randomized controlled trials existed. — Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+
• Additional yearly time-based interim analyses were added for the catheter and AmpC domains, with possible removal if recruitment stays insufficient. — Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+