ANZICS CTG Supported Study

The BALANCE study

Bacteremia antibiotic length actually needed for clinical effectiveness: randomised controlled trial
(was the BALANCE Pilot RCT CTG1516-03)

Study Description

Bloodstream infections are a common and serious problem, affecting 15% of critically ill patients and resulting in increased mortality. Optimal antibiotic treatment duration for these patients has not been studied. The aim of this study is to determine optimal treatment duration for bloodstream infections; maximizing clinical cure while minimizing antimicrobial treatment harms.

The BALANCE pilot RCT is to determine if it feasible to perform the main BALANCE RCT among critically ill patients with bloodstream infection to determine whether shorter duration antibiotic therapy (7 days) is as effective as longer duration antibiotic therapy (14 days)?

We hypothesize that the RCT will be feasible, as determined by:

• Adherence to antibiotic treatment protocols
• Timely recruitment

Management Committee

Nick Daneman, Rob Fowler, Deborah Cook, Steven Reynolds, John Muscedere, Rick Hall, Ruxandra Pinto, Rachael Parke, and Asgar Rishu.

Administering Institution

Sunnybrook Research Institute, and the Medical Research Institute of New Zealand.

Collaborators

Canadian Critical Care Trials Group
ANZICS Clinical Trials Group
CHUV, Lausanne,  Switzerland
King Abdulaziz Medical City Riyadh, KSA

Sample Size

3598 patients

Funding

Canadian Institute of Health Research; Ministry of Health and Long-term care alternate funding plan, Canada
Health Research Council of New Zealand

Project Status as of June 2018

Currently recruiting.

Contact

Rachael Parke (email)

Reference

CTG1718-03
NCT03005145