Evidence map›Paper›PMID 25903783›Full record

Trial reportTrials2015

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

Nick Daneman, Asgar H Rishu, Wei Xiong, Sean M Bagshaw, Deborah J Cook, Peter Dodek, Richard Hall, Anand Kumar, Francois Lamontagne, Francois Lauzier and 8 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02261506 (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02261506 nacompletednot on this map

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2014 to 2017Enrolled115ConditionsBacteremiaArms7 days of adequate antibiotic treatment durations, 14 days of adequate antibiotic treatment durations
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 10 institutions in 2 countries.

Nick DanemanDivision 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.
Asgar H RishuDepartment of Critical Care Medicine, Sunnybrook Health Sciences Center, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. asgar.rishu@sunnybrook.ca.
Wei XiongDepartment of Critical Care Medicine, Sunnybrook Health Sciences Center, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. wei.xiong@sunnybrook.ca.
Sean M BagshawDivision of Critical Care Medicine, University of Alberta Edmonton, 2-124E 8440-112 ST NW, Edmonton, AB, T6G 2B7, Canada. bagshaw@ualberta.ca.
Deborah J CookDivision of Critical Care Medicine, Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. debcook@mcmaster.ca.
Peter DodekDivision 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.
Richard HallDivision 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.
Anand KumarSection of Critical Care Medicine, University of Manitoba, 710 Park Blvd South, Winnipeg, MB, R3P 0X1, Canada. akumar61@yahoo.com.
Francois LamontagneCentre de recherche Clinique Étienne-Le Bel, 2500 boul. de l'Université, Université de Sherbrooke, Sherbrooke, QC, J1K 2R1, Canada. francoislamontagne@me.com.
Francois LauzierCentre 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.
John C MarshallDepartments of Surgery and Critical Care Medicine, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. marshallj@smh.ca.
Claudio M MartinDepartment of Medicine, London Health Sciences Centre, University of Western Ontario, 800 Commissioners Rd. E, London, ON, N6A 4G5, Canada. claudio.martin@lhsc.on.ca.
Lauralyn McIntyreDivision of Critical Care, Department of Medicine, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada. lmcintyre@ohri.ca.
John MuscedereDepartment of Medicine, Kingston General Hospital, Queen's University, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada. muscedej@kgh.kari.net.
Steven ReynoldsDepartment of Medicine, Royal Columbian Hospital, University of British Columbia, 260 Sherbrook Street, New Westminster, Vancouver, BC, V3L 3M2, Canada. sreynolds.md@gmail.com.
Henry T StelfoxDepartment of Critical Care Medicine, Institute of Public Health, University of Calgary, 1403 29 Street NW, Calgary, AB, T2N 2T9, Canada. tstelfox@ucalgary.ca.
Robert A FowlerDepartments 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.
Canadian Critical Care Trials Group
Sunnybrook Health Science Centre · CADalhousie University · CARoyal Columbian Hospital · CAUniversité de Sherbrooke · CAOttawa Hospital · CAQueen's University · CASt. Michael's Hospital · CASt. Paul's Hospital · CAUniversity of Alberta · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBacteremia 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/

designThis 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 registrationThe Pilot Trial was registered on 26 September 2014. TRIAL REGISTRATION NUMBER: NCT02261506.

Indexed as

Anti-Bacterial AgentsBacteremiaBiomarkersCalcitoninCalcitonin Gene-Related PeptideCanadaClinical ProtocolsCritical IllnessDrug Administration ScheduleFeasibility StudiesHumansIntensive Care UnitsLength of StayPilot ProjectsProtein PrecursorsResearch DesignAnti-Bacterial AgentsBiomarkersCALCA protein, humanCalcitoninCalcitonin Gene-Related PeptideProtein PrecursorsVasoconstrictor Agents

Identifiers

PMID25903783
PMCPMC4407544
OpenAlexW2006016478

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.