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.

Extensive research has demonstrated that shorter duration antibiotic treatment (less or equal to 7 days) is as effective as longer duration treatment for a variety of infectious diseases, but this question has not been directly studied in the setting of bloodstream infection. Our team’s systematic review of the medical literature, national survey of Canadian infectious diseases and critical care physicians, multicentre retrospective study and BALANCE pilot RCT, all support the need for a randomized controlled trial comparing shorter (7 days) versus longer (14 days) antibiotic therapy for bloodstream infections. Prior to performing the main trial, we completed a pilot trial to establish the feasibility of the research design, and to optimize the definitive trial. Since this intervention would require no new technology, and would reduce (rather than increase) health care costs, it would offer immediate benefits to patients and the healthcare system.

Management Committee

Nick Daneman (Chair), Rob Fowler (Chair), Yaseen Arabi, Deborah Cook, Rick Hall, John Muscedere, Ruxandra Pinto, Rachael Parke, Steven Reynolds and Asgar Rishu (Project Manager), Benjamin Rogers, Yahya Shehabi

Administering Institutions

Sunnybrook Research Institute
Medical Research Institute of New Zealand

Collaborators

Canadian Critical Care Trials Group
ANZICS CTG
USIIT group US
King Abdulaziz Medical City Riyadh, KSA
King Faisal Specialist Hospital Jeddah, KSA
Tel Aviv University, Israel
Cleveland Clinic, USA

Sample Size

3622 patients

Funding

Canadian Institute of Health Research; Ministry of Health and Long-term care alternate funding plan, Canada
NHMRC Project Grant, $1,230,000
Health Research Council of New Zealand Project Grant, $1,190,000

Project Status as of June 2019

In New Zealand, there are 10 participating sites in the BALANCE study. 8 sites are actively screening and steadily recruiting patients. The other two sites have all the regulatory requirements in place and will be activated once the database is installed in their hospital computers.

We have now enrolled a total of 38 patients. The recruitment for NZ sites is slower than expected and this relates to global recruitment as well. A protocol amendment to allow hospital-wide enrolment has been recently approved to boost recruitment numbers at interested sites. Data cleaning for the first interim analysis is underway.

Reference

CTG1718-03
NCT03005145

Contact

Rachael Parke (email)