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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03005145




Registration number
NCT03005145
Ethics application status
Date submitted
20/12/2016
Date registered
29/12/2016
Date last updated
29/02/2024

Titles & IDs
Public title
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness
Scientific title
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: Randomized Controlled Trial
Secondary ID [1] 0 0
0796
Universal Trial Number (UTN)
Trial acronym
BALANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacteremia 0 0
Intensive Care 0 0
Critically Ill 0 0
Sepsis 0 0
Mortality 0 0
Antimicrobial 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 7 days of adequate antibiotic treatment
Other interventions - 14 days of adequate antibiotic treatment.

Active Comparator: Short duration (7 days) - Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only

Active Comparator: Long duration (14 days) - Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only


Other interventions: 7 days of adequate antibiotic treatment
The choice of treatment including type, dose, route and interval of antibiotic will be left at the discretion of treating team as long as it is appropriate for the bacteremia

Other interventions: 14 days of adequate antibiotic treatment.
The choice of treatment including type, dose, route and interval of antibiotic will be left at the discretion of treating team as long as it is appropriate for the bacteremia
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
90 day survival
Timepoint [1] 0 0
90 days from index blood culture
Secondary outcome [1] 0 0
Hospital mortality
Timepoint [1] 0 0
Expected average of 4 weeks assessed upto one year
Secondary outcome [2] 0 0
ICU mortality
Timepoint [2] 0 0
Expected average of 2 weeks assessed upto one year
Secondary outcome [3] 0 0
Relapse rates of bacteremia with the same organism
Timepoint [3] 0 0
Upto 30 days after adequate antibiotic treatment
Secondary outcome [4] 0 0
Antibiotic allergy and adverse events
Timepoint [4] 0 0
Upto 30 days from start of antibiotic treatment
Secondary outcome [5] 0 0
Rates of C. difficile infection in hospital
Timepoint [5] 0 0
Upto 30 days after index blood culture collection date
Secondary outcome [6] 0 0
Rates of secondary nosocomial infection/colonization with antimicrobial resistant organisms in hospital
Timepoint [6] 0 0
Upto 30 days after index blood culture collection date
Secondary outcome [7] 0 0
ICU length of stay
Timepoint [7] 0 0
Expected for an average of 30 days assessed up to 1 year
Secondary outcome [8] 0 0
Hospital length of stay
Timepoint [8] 0 0
Expected for an average of 30 days assessed up to 1 year
Secondary outcome [9] 0 0
Mechanical ventilation duration
Timepoint [9] 0 0
Expected for an average of 30 days
Secondary outcome [10] 0 0
Antibiotic free days
Timepoint [10] 0 0
Upto 30 days after adequate antibiotic treatment

Eligibility
Key inclusion criteria
1. Patient is in ICU or non-ICU ward at the time the blood culture is drawn or reported
as positive.

2. Patient has a positive blood culture with pathogenic bacteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient already enrolled in the trial

2. Patient has severe immune system compromise, as defined by: absolute neutrophil count
<0.5x109/L; or is receiving immunosuppressive treatment for solid organ or bone marrow
or stem cell transplant

3. Patient has a prosthetic heart valve or synthetic endovascular graft (post major
vessel repair with synthetic material) (note: coronary artery stents are not an
exclusion)

4. Patient has documented or suspected syndrome with well-defined requirement for
prolonged treatment:

i) infective endocarditis; ii) osteomyelitis/septic arthritis; iii)
undrainable/undrained abscess; iv) unremovable/unremoved prosthetic-associated
infection (e.g. infected pacemaker, prosthetic joint infection, ventriculoperitoneal
shunt infection etc.) (note: central venous catheters, including tunneled central
intravenous catheter, and urinary catheters are not excluded unless the treating
clinical team does not have equipoise for enrollment and randomization to either
group)

5. Patient has a single positive blood culture with a common contaminant organism
according to Clinical Laboratory & Standards Institute (CLSI) Guidelines: coagulase
negative staphylococci; or Bacillus spp.; or Corynebacterium spp.; or
Propionobacterium spp.; or Aerococcus spp.; or Micrococcus spp.

6. Patient has a positive blood culture with Staphylococcus aureus or Staphylococcus
lugdunensis

7. Patient has a positive blood culture with Candida spp. or other fungal species.

8. Blood culture grows rare bacterial pathogens requiring prolonged treatment (e.g.
Mycobacteria spp., Nocardia spp., Actinomyces spp., Brucella spp., Burkholderia
pseudomallei)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2023
Sample size
Target
Accrual to date
Final
3622
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Bankstown Hospital - Bankstown
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
St. George Hospital - Kogarah
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Wollongong Hospital ICU - Wollongong
Recruitment hospital [7] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 0 0
Ballarat Hospital - Ballarat
Recruitment hospital [9] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [10] 0 0
Casey Hospital - Berwick
Recruitment hospital [11] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [12] 0 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [13] 0 0
Frankston Hospital - Frankston
Recruitment hospital [14] 0 0
Peninsula Private Hospital - Langwarrin
Recruitment hospital [15] 0 0
Cabrini Health - Malvern
Recruitment hospital [16] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [17] 0 0
St John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- New Lambton Heights
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment postcode(s) [6] 0 0
- Wollongong
Recruitment postcode(s) [7] 0 0
- Birtinya
Recruitment postcode(s) [8] 0 0
- Ballarat
Recruitment postcode(s) [9] 0 0
- Bendigo
Recruitment postcode(s) [10] 0 0
- Berwick
Recruitment postcode(s) [11] 0 0
- Clayton
Recruitment postcode(s) [12] 0 0
- Dandenong
Recruitment postcode(s) [13] 0 0
- Frankston
Recruitment postcode(s) [14] 0 0
- Langwarrin
Recruitment postcode(s) [15] 0 0
- Malvern
Recruitment postcode(s) [16] 0 0
- Murdoch
Recruitment postcode(s) [17] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
Newfoundland and Labrador
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Israel
State/province [10] 0 0
Tel Aviv
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
New Zealand
State/province [13] 0 0
Hamilton
Country [14] 0 0
New Zealand
State/province [14] 0 0
New Plymouth
Country [15] 0 0
New Zealand
State/province [15] 0 0
Rotorua
Country [16] 0 0
New Zealand
State/province [16] 0 0
Wellington
Country [17] 0 0
Saudi Arabia
State/province [17] 0 0
Jeddah
Country [18] 0 0
Saudi Arabia
State/province [18] 0 0
Riyadh
Country [19] 0 0
Switzerland
State/province [19] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Sunnybrook Health Sciences Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The World Health Organization, U.S. Centers for Disease Control and Prevention, Association
of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all
declared antimicrobial resistance a global threat to health, based on rapidly increasing
resistance rates and declining new drug development. Up to 30-50% of antibiotic use is
inappropriate, and excessive durations of treatment are the greatest contributor to
inappropriate use. Shorter duration treatment (=7 days) has been shown in meta-analyses to be
as effective as longer antibiotic treatment for a range of mild to moderate infections. A
landmark trial in critically ill patients with ventilator-associated pneumonia showed that
mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of
treatment. Similar adequately powered randomized trial evidence is lacking for the treatment
of patients with bloodstream infections caused by a wide spectrum of organisms.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03005145
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nick Daneman, MD
Address 0 0
Sunnybrook Health Sciences Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries