BacteremiaBALANCE-WardsNCT02917551
BALANCE on the Wards: A Pilot RCT
A study testing 7 days of adequate antibiotic treatment and 14 days of adequate antibiotic treatment in people with Bacteremia, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.
Trial summary
The burden of bloodstream infections is large and increasing over time. Antibiotic overuse continues to drive increased rates of antimicrobial-resistant pathogens across Canada. However, prospective audits have revealed that 30-50% of antibiotic utilization is unnecessary or inappropriate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacteremia
- What is being tested?
- 7 days of adequate antibiotic treatment and 14 days of adequate antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesCanada
- Study dates
- 10 Oct 2016to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is in the hospital ward and not in the intensive care units at time the blood culture result reported as positive AND
- Patient has a positive blood culture with pathogenic bacteria
Who cannot join
- Patient already enrolled in either of the BALANCE trials
- Patient is admitted in the ICU at the time of enrollment
- 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
- Patient has a prosthetic heart valve or synthetic endovascular graft
- Patient has documented or suspicion of syndrome with well-defined requirement for prolonged treatment:
- infective endocarditis; ii) osteomyelitis/septic arthritis; iii) undrainable/undrained abscess; iv) unremovable/unremoved prosthetic-associated infection
Show all 9Show fewer
- 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.
- Patient has a positive blood culture with Staphylococcus aureus.
- Patient has a positive blood culture with Candida spp. or other fungal species.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Hamilton General Hospital
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
The Ottawa Hospital
Ottawa, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
North York General Hospital
Toronto, Ontario
St. Joseph's Health Centre
Toronto, Ontario
About this study
Official title: Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness- BALANCE on the Wards: A Pilot RCT
The burden of bloodstream infections is large and increasing over time. Antibiotic overuse continues to drive increased rates of antimicrobial-resistant pathogens across Canada. However, prospective audits have revealed that 30-50% of antibiotic utilization is unnecessary or inappropriate. If shorter duration therapy is as effective as longer duration therapy for these infections, antimicrobial consumption would be decreased. A pilot trial (approved by the Sunnybrook Research Ethics Board), is underway in critically ill patients at 17 Canadian ICUs. Investigators have successfully demonstrated feasibility with respect to protocol adherence and recruitment rates in the ICU. Investigators now aim to conduct a similar pilot RCT among non-ICU patients admitted to hospital wards with bloodstream infections to determine feasibility and protocol adherence of the same trial protocol.
Read the detailed description
Bloodstream infections are a common and serious problem, and are associated with increased morbidity and mortality. At the same time, antibiotic overuse is also a common and serious problem, in that 30-50% of antibiotic use is unnecessary or inappropriate, and results in avoidable drug side effects such as kidney failure, Clostridium difficile infection, increased costs, and spiraling antibiotic resistance rates. The greatest contributor to antibiotic overuse is excessive durations of treatment.
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, and multicentre retrospective study 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, our pilot RCT in critically ill patients is near-completion.
In order to increase the generalizability to non-critically ill patients, Investigators want to conduct a similar pilot RCT in non-critically ill patients (BALANCE on the Wards) to establish the feasibility of the research design, and to optimize the definitive trial.
Investigators will conduct a randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for patients with bloodstream infections across all non-ICU hospital wards in Sunnybrook Hospital (BALANCE on the Wards). Our ongoing BALANCE pilot RCT in ICU is approved by the Sunnybrook REB (PIN: 187-2014). The BALANCE on Wards pilot trial will use the same protocol, informed consent form and the case report forms that are approved by the Sunnybrook REB with minimal changes to make it ward specific. If the investigators are able to achieve the primary outcome of this trial in Sunnybrook hospital, the main BALANCE trial will potentially involve enrolment of non-ICU patients at all (or a subset of) participating sites.
If eligibility criteria and study procedures are substantially unchanged, results of the both the pilot BALANCE RCTs will be rolled into the dataset for the main BALANCE RCT.
- Conditions
- Bacteremia
- Being tested
- 7 days of adequate antibiotic treatment, 14 days of adequate antibiotic treatment
- Keywords
- Bacteremia, duration, non-critically ill, non-ICU
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days of adequate antibiotic treatmentOther
14 days of adequate antibiotic treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Shorter duration (7 days) | Active comparator | Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only Receives: Other: 7 days of adequate antibiotic treatment |
| Longer duration (14 days) | Active comparator | Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only Receives: Other: 14 days of adequate antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
defined by: (a) the adherence to treatment duration protocol (proportion of treatment courses); and (b) the rate of recruitment (enrolled per month). Investigators will consider enrolling patients in hospital wards for the BALANCE main trial if 90% of antibiotic treatment courses are within 7± 2 days in the shorter duration treatment arm or 14 ± 2 days in the longer duration treatment arm; and, if recruitment rates of at least 4 patients per 4 weeks is achieved.
Measured: 15 days
Secondary outcomes (8)
Hospital mortality rates
Measured: recorded as alive or dead at hospital discharge following index positive blood culture for an expected average of 4 weeks assesses upto one year.
90-day mortality rates
Measured: recorded as alive or dead at 90 days following index positive blood culture
Relapse rates of bacteremia
Defined as the recurrence of bacteremia due to original infecting organism (same Genus and species) after documentation of negative blood cultures or clinical improvement and within 30 days after completing course of adequate antimicrobial therapy.
Measured: upto 30 days after adequate antibiotic treatment
Antibiotic allergy and adverse events
Measured: up to 30 days from start of antibiotic treatment.
Rates of C. difficile infection in hospital
Measured: Upto 30 days after index blood culture collection date
Rates of secondary nosocomial infection with antimicrobial resistant organisms in hospital
Measured: upto 30 days after index blood culture collection date
Hospital length of stay
Measured: for the duration of Hospital stay, expected for an average of 30 days assessed up to 1 year
Antibiotic free days
Measured: no. of days patient remained without antibiotics for up to 30 days post index blood culture collection date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start10 Oct 2016
- Primary completion30 Nov 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Daneman, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917551
- Sponsor's protocol ID
- 218-2016
- Acronym
- BALANCE-Wards
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2016
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Daneman N, Rishu AH, Pinto R, Arabi Y, Belley-Cote EP, Cirone R, Downing M, Cook DJ, Hall R, McGuinness S, McIntyre L, Muscedere J, Parke R, Reynolds S, Rogers BA, Shehabi Y, Shin P, Whitlock R, Fowler RA; Canadian Critical Care Trials Group. A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards. Trials. 2020 Jan 15;21(1):92. doi: 10.1186/s13063-019-4033-9.
PubMed 31941546
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness- BALANCE on the Wards: A Pilot RCT
- ClinicalTrials.gov ID
- NCT02917551
- Acronym / sponsor ID
- BALANCE-Wards / 218-2016
- Conditions
- Bacteremia
- Keywords
- Bacteremia, duration, non-critically ill, non-ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The burden of bloodstream infections is large and increasing over time. Antibiotic overuse continues to drive increased rates of antimicrobial-resistant pathogens across Canada. However, prospective audits have revealed that 30-50% of antibiotic utilization is unnecessary or inappropriate. If shorter duration therapy is as effective as longer duration therapy for these infections, antimicrobial consumption would be decreased. A pilot trial (approved by the Sunnybrook Research Ethics Board), is underway in critically ill patients at 17 Canadian ICUs. Investigators have successfully demonstrated feasibility with respect to protocol adherence and recruitment rates in the ICU. Investigators now aim to conduct a similar pilot RCT among non-ICU patients admitted to hospital wards with bloodstream infections to determine feasibility and protocol adherence of the same trial protocol.
Detailed description
Bloodstream infections are a common and serious problem, and are associated with increased morbidity and mortality. At the same time, antibiotic overuse is also a common and serious problem, in that 30-50% of antibiotic use is unnecessary or inappropriate, and results in avoidable drug side effects such as kidney failure, Clostridium difficile infection, increased costs, and spiraling antibiotic resistance rates. The greatest contributor to antibiotic overuse is excessive durations of treatment.
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, and multicentre retrospective study 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, our pilot RCT in critically ill patients is near-completion.
In order to increase the generalizability to non-critically ill patients, Investigators want to conduct a similar pilot RCT in non-critically ill patients (BALANCE on the Wards) to establish the feasibility of the research design, and to optimize the definitive trial.
Investigators will conduct a randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for patients with bloodstream infections across all non-ICU hospital wards in Sunnybrook Hospital (BALANCE on the Wards). Our ongoing BALANCE pilot RCT in ICU is approved by the Sunnybrook REB (PIN: 187-2014). The BALANCE on Wards pilot trial will use the same protocol, informed consent form and the case report forms that are approved by the Sunnybrook REB with minimal changes to make it ward specific. If the investigators are able to achieve the primary outcome of this trial in Sunnybrook hospital, the main BALANCE trial will potentially involve enrolment of non-ICU patients at all (or a subset of) participating sites.
If eligibility criteria and study procedures are substantially unchanged, results of the both the pilot BALANCE RCTs will be rolled into the dataset for the main BALANCE RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shorter duration (7 days) | Active comparator | Other: 7 days of adequate antibiotic treatmentPatients in 7 day arm will receive adequate antibiotics until the end of day 7 only |
| Longer duration (14 days) | Active comparator | Other: 14 days of adequate antibiotic treatmentPatients in 14 day arm will receive adequate antibiotics until the end of day 14 only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is in the hospital ward and not in the intensive care units at time the blood culture result reported as positive AND
- Patient has a positive blood culture with pathogenic bacteria
Key exclusion criteria (9 listed)
- Patient already enrolled in either of the BALANCE trials
- Patient is admitted in the ICU at the time of enrollment
- 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
- Patient has a prosthetic heart valve or synthetic endovascular graft
- Patient has documented or suspicion of syndrome with well-defined requirement for prolonged treatment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 days of adequate antibiotic treatment | Other | Shorter duration (7 days) |
| 14 days of adequate antibiotic treatment | Other | Longer duration (14 days) |
Primary outcome
Feasibility
Time frame: 15 days
defined by: (a) the adherence to treatment duration protocol (proportion of treatment courses); and (b) the rate of recruitment (enrolled per month). Investigators will consider enrolling patients in hospital wards for the BALANCE main trial if 90% of antibiotic treatment courses are within 7± 2 days in the shorter duration treatment arm or 14 ± 2 days in the longer duration treatment arm; and, if recruitment rates of at least 4 patients per 4 weeks is achieved.
8 secondary outcomes
Hospital mortality rates
Time frame: recorded as alive or dead at hospital discharge following index positive blood culture for an expected average of 4 weeks assesses upto one year.
90-day mortality rates
Time frame: recorded as alive or dead at 90 days following index positive blood culture
Relapse rates of bacteremia
Time frame: upto 30 days after adequate antibiotic treatment
Antibiotic allergy and adverse events
Time frame: up to 30 days from start of antibiotic treatment.
Rates of C. difficile infection in hospital
Time frame: Upto 30 days after index blood culture collection date
Rates of secondary nosocomial infection with antimicrobial resistant organisms in hospital
Time frame: upto 30 days after index blood culture collection date
Hospital length of stay
Time frame: for the duration of Hospital stay, expected for an average of 30 days assessed up to 1 year
Antibiotic free days
Time frame: no. of days patient remained without antibiotics for up to 30 days post index blood culture collection date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Derived from this study: PubMed 31941546Daneman N, Rishu AH, Pinto R, Arabi Y, Belley-Cote EP, Cirone R, Downing M, Cook DJ, Hall R, McGuinness S, McIntyre L, Muscedere J, Parke R, Reynolds S, Rogers BA, Shehabi Y, Shin P, Whitlock R, Fowler RA; Canadian Critical Care Trials Group. A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards. Trials. 2020 Jan 15;21(1):92. doi: 10.1186/s13063-019-4033-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Daneman, MD principal investigator
Sunnybrook Health Sciences Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 days of adequate antibiotic treatment and 14 days of adequate antibiotic treatment in people with Bacteremia, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.