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BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections

ClinicalTrials.gov · COMPLETED, 2024

174 participants

Abstract

The goal of the BALANCE+ clinical trial is to transform random care to randomized care for patients with Gram negative bloodstream infections to inform best treatment approaches and optimize outcomes.

BALANCE+, a perpetual platform trial, will efficiently answer multiple questions that are important for hospitalized patients with Gram negative bloodstream infections.

Conditions: Gram-negative Bacteremia.

Primary outcome: Recruitment rate (co-primary outcomes of BALANCE+ vanguard phase); Protocol adherence (co-primary outcomes of BALANCE+ vanguard phase); De-escalation versus no de-escalation domain; Oral beta-lactam versus non beta-lactam domain; Central vascular catheter retention versus replacement domain; Low-risk AmpC domain; Follow-up blood culture domain.

Enrollment: 174 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 174 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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