Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot...

Area of Science:

• Critical Care Medicine
• Infectious Diseases
• Clinical Trials

Background:

• Bacteremia is a significant cause of mortality and morbidity in critically ill adults.
• Current evidence lacks direct comparison of shorter versus longer antimicrobial treatment durations in this population.

Purpose of the Study:

• To conduct a pilot randomized controlled trial (RCT) evaluating the feasibility of comparing 7-day versus 14-day antimicrobial treatment durations for bacteremia in critically ill patients.
• To inform the design of a subsequent main RCT.

Main Methods:

• Multicenter pilot RCT involving critically ill adults with bacteremia.
• Patients randomized to 7 or 14 days of adequate antimicrobial treatment.
• Feasibility assessed by recruitment rate and protocol adherence; primary outcome for main trial is 90-day mortality.

Main Results:

• Feasibility outcomes (recruitment rate, adherence) will be reported upon trial completion.
• Secondary outcomes include mortality, relapse, adverse events, and infection rates.

Conclusions:

• The BALANCE pilot trial is crucial for designing a definitive RCT on antimicrobial treatment duration for bacteremia.
• Results will establish an evidence basis for treatment decisions in critically ill patients.