NCT02261506: BALANCE

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT

Completed NA Last updated 18 December 2017

What this trial tests

NA trial testing 7 days of adequate antibiotic treatment durations in Bacteremia in 115 participants. Completed in 5 October 2017.

Timeline

16 October 2014

Primary endpoint
30 August 2017

5 October 2017

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	115
Start date	16 October 2014
Primary completion	30 August 2017
Estimated completion	5 October 2017
Sites	17 locations across Canada

Drugs / interventions tested

• 7 days of adequate antibiotic treatment durations
• 14 days of adequate antibiotic treatment durations

Conditions studied

• Bacteremia — all drugs for Bacteremia →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

18 and older, any sex, with Bacteremia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and soft tissue sources), because of the high attendant morbidity and mortality of bacteremia, these patients collectively represent a critically important group to study.

The consequences of the excessive antimicrobial use for individual patients, range from rash, gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One particularly concerning complication, Clostridium difficile infection, has increased in incidence and severity over the past decade. Much of this burden could be prevented through reduction in unnecessary antibiotic use.

Another major consequence of excessive antibiotic use is antimicrobial resistance. Antibiotic resistance is not only a concern for the patient who receives antibiotics, but also for neighbouring patients in the ICU, as well as future patients in the ICU and the hospital at large - through patient-to-patient transmission, and environmental contamination.

No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. The investigators will conduct a multi-center randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for critically ill patients with bacteremia admitted to ICU. Eligible, patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment. The selection of type, dose and route of antibiotics will be at the discretion of the treating physicians, but the duration of treatment (7 versus 14 days) will be determined by randomization group. The randomization assignment will not be communicated to the study research coordinator, study critical care or infectious diseases investigators or clinicians until day 8. The primary outcome for the main trial will be 90-day mortality.

The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional funds are obtained the investigators will also roll out to the other Canadian ICUs listed below. The goal of adding these additional sites will be to increase the generalizability of the findings with respect to trial feasibility

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial.
   Daneman N, Rishu AH, Pinto R, Aslanian P, et al · · 2018 · cited 35× · PMID 29452598 · DOI 10.1186/s13063-018-2474-1
2. Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol.
   Daneman N, Rishu AH, Pinto RL, Arabi YM, et al · · 2020 · cited 22× · PMID 32398341 · DOI 10.1136/bmjopen-2020-038300
3. Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial.
   Daneman N, Rishu AH, Xiong W, Bagshaw SM, et al · · 2015 · cited 18× · PMID 25903783 · DOI 10.1186/s13063-015-0688-z
4. A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards.
   Daneman N, Rishu AH, Pinto R, Arabi Y, et al · · 2020 · cited 9× · PMID 31941546 · DOI 10.1186/s13063-019-4033-9