BALANCE on the Wards: A Pilot RCT (BALANCE-Wards)
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|ClinicalTrials.gov Identifier: NCT02917551|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bacteremia||Other: 7 days of adequate antibiotic treatment Other: 14 days of adequate antibiotic treatment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness- BALANCE on the Wards: A Pilot RCT|
|Actual Study Start Date :||October 10, 2016|
|Estimated Primary Completion Date :||January 10, 2020|
|Estimated Study Completion Date :||January 20, 2020|
Active Comparator: Shorter duration (7 days)
Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only
Other: 7 days of adequate antibiotic treatment
Active Comparator: Longer duration (14 days)
Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only
Other: 14 days of adequate antibiotic treatment
- 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.
- 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 ]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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917551
|Contact: Nick Daneman, MDemail@example.com|
|Contact: Rob Fowler, MDfirstname.lastname@example.org|
|Hamilton General Hospital||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Richard Whitlock, MD|
|Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada|
|Contact: John Muscedere, MD|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada|
|Contact: Lauralyn McIntyre, MD|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Nick Daneman, MD 4164806100 ext 2791 email@example.com|
|Sub-Investigator: Rob A Fowler, MD|
|North York General Hospital||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Phil Shin, MD|
|St. Joseph's Health Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Robert Cirone, MD|
|Principal Investigator:||Nick Daneman, MD||Sunnybrook Health Sciences Centre|