Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT
NCT ID: NCT02261506
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
115 participants
INTERVENTIONAL
2014-10-16
2017-10-05
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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7 days
Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only
7 days of adequate antibiotic treatment durations
We will not be randomizing patients to any specific antibiotic regimen. Patients will be randomized to fixed durations of adequate treatment: 7 versus 14 days. The selection of antibiotic(s) will be at the discretion of the treating team, although the research team will check to ensure that the selected antibiotics have an 'adequate' spectrum of coverage for the bacterial pathogen(s) isolated in the blood culture.
14 days
Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only
14 days of adequate antibiotic treatment durations
Interventions
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7 days of adequate antibiotic treatment durations
We will not be randomizing patients to any specific antibiotic regimen. Patients will be randomized to fixed durations of adequate treatment: 7 versus 14 days. The selection of antibiotic(s) will be at the discretion of the treating team, although the research team will check to ensure that the selected antibiotics have an 'adequate' spectrum of coverage for the bacterial pathogen(s) isolated in the blood culture.
14 days of adequate antibiotic treatment durations
Eligibility Criteria
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Inclusion Criteria
* Patient has a positive blood culture with pathogenic bacteria.
Exclusion Criteria
* 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 syndrome with well-defined requirement for prolonged treatment:
* infective endocarditis
* osteomyelitis/septic arthritis
* undrainable/undrained abscess
* unremovable/unremoved prosthetic-associated infection
* 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.
18 Years
ALL
No
Sponsors
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Kingston Health Sciences Centre
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Nick Daneman
Clinician Scientist
Principal Investigators
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Nick Daneman, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Foothills Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
CHUM
Montreal, Quebec, Canada
Centre hospitalier affilié universitaire de Québec
Québec, Quebec, Canada
CSSS de Trois-Rivières
Québec, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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References
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Daneman N, Rishu AH, Pinto R, Aslanian P, Bagshaw SM, Carignan A, Charbonney E, Coburn B, Cook DJ, Detsky ME, Dodek P, Hall R, Kumar A, Lamontagne F, Lauzier F, Marshall JC, Martin CM, McIntyre L, Muscedere J, Reynolds S, Sligl W, Stelfox HT, Wilcox ME, Fowler RA; Canadian Critical Care Trials Group. 7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial. Trials. 2018 Feb 17;19(1):111. doi: 10.1186/s13063-018-2474-1.
Daneman N, Rishu AH, Xiong W, Bagshaw SM, Cook DJ, Dodek P, Hall R, Kumar A, Lamontagne F, Lauzier F, Marshall JC, Martin CM, McIntyre L, Muscedere J, Reynolds S, Stelfox HT, Fowler RA; Canadian Critical Care Trials Group. Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial. Trials. 2015 Apr 18;16:173. doi: 10.1186/s13063-015-0688-z.
Other Identifiers
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187-2014
Identifier Type: -
Identifier Source: org_study_id