ANZICS CTG Supported Study

BALANCE

The BALANCE Study (Bacteraemia Antibiotic Length Actually Needed for Clinical Effectiveness): randomised controlled trial

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 surveys of Canadian and Australian 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, Asgar Rishu, 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, New York University, USA, University of Bern, Switzerarland

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

BALANCE study is enrolling steadily in New Zealand. 9 sites are actively recruiting ICU patients in the study. A total of 151 patients enrolled. Recruitment in NZ has improved after engaging with the ID team of each site. The global recruitment is slowly picking up with more sites also enrolling in the wards. In NZ, BALANCE recruitment is in ICU only. The Balance Urinary Sepsis Sub-study has started recruiting in NZ with Rotorua, Waikato and Wellington participating.                                                                                                                                                                          Currently, we are at 62% of target recruitment (2,247/3,622). There are 70 sites in total with 34 of these sites enrolling in ICU only, 20 enrolling in both ICU and wards and 1 enrolling on wards only

Reference

CTG1718-03 | NCT03005145 | ACTRN12620001108909 (Australian Urinary Sepsis sub-study)

Contact

Rachael Parke

RParke@adhb.govt.nz