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The BALANCE Study

ANZICS CTG Supported Study

The BALANCE study

The BALANCE Study (Bacteraemia 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 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.

The BALANCE study is a multi-centre international randomised trial. It is investigating the optimal length of antimicrobial therapy for patients with bacteraemia managed in the hospital. Patients that meet inclusion criteria are randomised to 7 or 14 days of total antimicrobial therapy. The study aims to recruit 3600 participants over five years (2018-2022) at more than 50 sites globally. Entry criteria are pragmatic and recruitment is up until day +7 after bacteraemia allowing a workable time-frame for enrolment.

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.

The Australian arm of the study has been funded by an NHMRC Project grant and we are looking for further Australian sites. The Australian and New Zealand coordinating centres provide assistance with start-up and ongoing support through the study. Funding is provided to support start-up and on a per-patient basis for recruitment.

BALANCE is co-endorsed by the ANZICS-CTG and the Australasian Society for Infectious Diseases – Clinical Research Network (ASID-CRN)

Progress

In Australia 13 sites are actively recruiting patients for BALANCE. These sites are recruiting a mix of patients who have received ICU and ward-level care. There are a further 4 sites scheduled to initiate in the first half of 2021. To date 145 patients have been randomised in Australia of a total expected recruitment of 800 patients. Site initiation and recruitment was delayed by COVID-19 but has fortunately recovered in the last quarter of 2020 and early 2021.

In New Zealand, there are 9 sites actively screening and recruiting patients. All these sites are only enrolling in ICU. 126 patients in total have been enrolled into the study. To boost recruitment, the BALANCE NZ study team have been engaging with ICU/ID teams of participating sites via a series of meetings/teleconferences.

Administering Institution
Monash University
Medical Research Institute of New Zealand

Reference

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

Contact

New Zealand:

Colin McArthur – ColinM@adhb.govt.nz
Shay McGuinness – ShayMc@adhb.govt.nz
Rachael Parke – RParke@adhb.govt.nz
Raulle Sol Cruz – raulle.solcruz@mrinz.ac.nz
Susan Morpeth – susan.morpeth@middlemore.co.nz

Australia:

Dhiraj B Dwivedi – balance.australia@monash.edu
A/Prof Ben Rogers – ben.rogers@monash.edu
Prof Yahya Shehabi – Yahya.shehabi@monash.edu