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Trials. 2015 Apr 18;16:173. doi: 10.1186/s13063-015-0688-z.

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial.

Author information

1
Division of Infectious Diseases & Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto and Adjunct Scientist, Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, Ontario, M4N 3M5, Canada. nick.daneman@sunnybrook.ca.
2
Department of Critical Care Medicine, Sunnybrook Health Sciences Center, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. asgar.rishu@sunnybrook.ca.
3
Department of Critical Care Medicine, Sunnybrook Health Sciences Center, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. wei.xiong@sunnybrook.ca.
4
Division of Critical Care Medicine, University of Alberta Edmonton, 2-124E 8440-112 ST NW, Edmonton, AB, T6G 2B7, Canada. bagshaw@ualberta.ca.
5
Division of Critical Care Medicine, Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. debcook@mcmaster.ca.
6
Division of Critical Care Medicine and Center for Health Evaluation and Outcome Sciences, St Paul's Hospital and University of B.C, 1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. peter.dodek@ubc.ca.
7
Division of Critical Care Medicine, Department of Anesthesiology, Dalhousie University and the Capital District, Health Authority, 5790 University Avenue, Halifax, NS, B3H 1V7, Canada. r.i.hall@dal.ca.
8
Section of Critical Care Medicine, University of Manitoba, 710 Park Blvd South, Winnipeg, MB, R3P 0X1, Canada. akumar61@yahoo.com.
9
Centre de recherche Clinique Étienne-Le Bel, 2500 boul. de l'Université, Université de Sherbrooke, Sherbrooke, QC, J1K 2R1, Canada. francoislamontagne@me.com.
10
Centre de recherche FRQS du Centre hospitalier affilié universitaire de Québec, Axe Traumatologie - urgence - soins intensifs, Division de soins intensifs adultes, départements de médecine et d'anesthésiologie, Université Laval, 1401, 18e Rue, Québec, QC, G1J 1Z4, Canada. francois.lauzier@med.ulaval.ca.
11
Departments of Surgery and Critical Care Medicine, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. marshallj@smh.ca.
12
Department of Medicine, London Health Sciences Centre, University of Western Ontario, 800 Commissioners Rd. E, London, ON, N6A 4G5, Canada. claudio.martin@lhsc.on.ca.
13
Division of Critical Care, Department of Medicine, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada. lmcintyre@ohri.ca.
14
Department of Medicine, Kingston General Hospital, Queen's University, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada. muscedej@kgh.kari.net.
15
Department of Medicine, Royal Columbian Hospital, University of British Columbia, 260 Sherbrook Street, New Westminster, Vancouver, BC, V3L 3M2, Canada. sreynolds.md@gmail.com.
16
Department of Critical Care Medicine, Institute of Public Health, University of Calgary, 1403 29 Street NW, Calgary, AB, T2N 2T9, Canada. tstelfox@ucalgary.ca.
17
Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Center, University of Toronto, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. rob.fowler@sunnybrook.ca.

Abstract

BACKGROUND:

Bacteremia is a leading cause of mortality and morbidity in critically ill adults. No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients.

METHODS/DESIGN:

This is a multicenter pilot randomized controlled trial in critically ill patients with bacteremia. Eligible patients will be adults with a positive blood culture with pathogenic bacteria identified while in the intensive care unit. Eligible, consented patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment for the causative pathogen(s) detected on blood cultures. The diversity of pathogens and treatment regimens precludes blinding of patient and clinicians, but allocation concealment will be extended to day 7 and outcome adjudicators will be blinded. The primary outcome for the main trial will be 90-day mortality. The primary outcome for the pilot trial is feasibility defined by (i) rate of recruitment exceeding 1 patient per site per month and (ii) adherence to treatment duration protocol  ≥  90%. Secondary outcomes include intensive care unit, hospital and 90-day mortality rates, relapse rates of bacteremia, antibiotic-related side effects and adverse events, rates of Clostridium difficile infection, rates of secondary infection or colonization with antimicrobial resistant organisms, ICU and hospital lengths of stay, mechanical ventilation and vasopressor duration in intensive care unit, and procalcitonin levels on the day of randomization, and day 7, 10 and 14 after the index blood culture.

DISCUSSION:

The BALANCE pilot trial will inform the design and execution of the subsequent BALANCE main trial, which will evaluate shorter versus longer duration treatment for bacteremia in critically ill patients, and thereby provide an evidence basis for treatment duration decisions for these infections.

TRIAL REGISTRATION:

The Pilot Trial was registered on 26 September 2014.

TRIAL REGISTRATION NUMBER:

NCT02261506.

PMID:
25903783
PMCID:
PMC4407544
DOI:
10.1186/s13063-015-0688-z
[Indexed for MEDLINE]
Free PMC Article

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