Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol.

Humans Anti-Bacterial Agents / administration & dosage Bacteremia / drug therapy Cross Infection / drug therapy Drug Administration Schedule Recurrence Selection Bias Treatment Outcome Randomized Controlled Trials as Topic Multicenter Studies as Topic
adult intensive & critical care bacteriology infectious diseases

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
11 05 2020
Historique:
entrez: 14 5 2020
pubmed: 14 5 2020
medline: 16 2 2021
Statut: epublish

Résumé

Bloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied. We will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors ( The study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital. The BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).

Identifiants

DOI: 10.1136/bmjopen-2020-038300 PMID: 32398341 PMC: PMC7223357
pubmed: 32398341
pii: bmjopen-2020-038300
doi: 10.1136/bmjopen-2020-038300
pmc: PMC7223357
doi:

Substances chimiques

Anti-Bacterial Agents 0

Banques de données

ClinicalTrials.gov
['NCT03005145']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e038300

Subventions

Organisme : CIHR
Pays : Canada

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Références

N Engl J Med. 2004 May 27;350(22):2247-56
pubmed: 15163774
JAMA. 2012 Dec 26;308(24):2605-11
pubmed: 23268519
Infect Dis Clin North Am. 2009 Jun;23(2):269-76, Table of Contents
pubmed: 19393908
N Engl J Med. 2013 Feb 28;368(9):795-805
pubmed: 23339639
J Crit Care. 1998 Dec;13(4):159-63
pubmed: 9869541
Clin Infect Dis. 2010 Jan 15;50(2):133-64
pubmed: 20034345
Clin Infect Dis. 2008 Sep 15;47(6):735-43
pubmed: 18694344
Crit Care Med. 2006 Jun;34(6):1589-96
pubmed: 16625125
Clin Infect Dis. 2003 Sep 15;37(6):752-60
pubmed: 12955634
JAMA Intern Med. 2013 Apr 22;173(8):673-82
pubmed: 23552741
Crit Care Med. 2009 Jan;37(1):81-8
pubmed: 19050636
Lancet. 2002 Sep 14;360(9336):835-41
pubmed: 12243918
Intensive Crit Care Nurs. 2013 Dec;29(6):300-9
pubmed: 23871290
BMC Med Res Methodol. 2019 Mar 29;19(1):71
pubmed: 30925900
Crit Care Med. 2016 Feb;44(2):256-64
pubmed: 26496448
Antimicrob Agents Chemother. 2010 Nov;54(11):4851-63
pubmed: 20733044
J Crit Care. 2011 Oct;26(5):533.e11-533.e22
pubmed: 21376518
BMJ. 2002 Sep 21;325(7365):652-4
pubmed: 12242181
Arch Intern Med. 2004 Aug 9-23;164(15):1669-74
pubmed: 15302637
Intensive Care Med. 2013 Aug;39(8):1484-6
pubmed: 23812338
Comput Methods Programs Biomed. 2003 Oct;72(2):117-25
pubmed: 12941516
Int J Antimicrob Agents. 2011 Dec;38(6):480-5
pubmed: 21982833
BMJ. 2017 Jul 26;358:j3418
pubmed: 28747365
Crit Care Med. 2011 Aug;39(8):1859-65
pubmed: 21499086
Clin Infect Dis. 2007 Mar 1;44 Suppl 2:S27-72
pubmed: 17278083
Int J Antimicrob Agents. 2019 Aug;54(2):184-188
pubmed: 31085297
Lancet. 2005 Feb 19-25;365(9460):711-22
pubmed: 15721478
Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416
pubmed: 15699079
Clin Microbiol Infect. 2013 Jun;19(6):501-9
pubmed: 23473333
Clin Infect Dis. 2007 Jan 15;44(2):159-77
pubmed: 17173212
J Antimicrob Chemother. 2004 Aug;54(2):515-23
pubmed: 15269191
Lancet. 2012 Aug 4;380(9840):484-90
pubmed: 22726802
BMJ. 2004 Apr 3;328(7443):791
pubmed: 15070633
J Hosp Infect. 2006 Jun;63(2):124-32
pubmed: 16621137
Thromb Res. 2013 Mar;131(3):204-9
pubmed: 23317632
JAMA. 2009 Dec 2;302(21):2323-9
pubmed: 19952319
Clin Infect Dis. 2011 Mar 1;52(5):e103-20
pubmed: 21292654
Clin Infect Dis. 2011 Jul 1;53(1):42-8
pubmed: 21653301
BMJ. 2010 Mar 23;340:c869
pubmed: 20332511
Crit Care. 2011;15(6):R267
pubmed: 22085732
J Crit Care. 2013 Feb;28(1):28-39
pubmed: 23089679
JAMA. 2019 Apr 23;321(16):1631-1632
pubmed: 31012923
N Engl J Med. 2019 Jan 31;380(5):415-424
pubmed: 30152252
JAMA. 2003 Nov 19;290(19):2588-98
pubmed: 14625336
Clin Infect Dis. 2009 Jul 1;49(1):1-45
pubmed: 19489710
Can J Infect Dis Med Microbiol. 2013 Fall;24(3):129-37
pubmed: 24421823
Lancet. 2010 Feb 6;375(9713):463-74
pubmed: 20097417
JAMA. 2012 Dec 26;308(24):2594-604
pubmed: 23268518
Crit Care Med. 2019 Oct;47(10):1324-1331
pubmed: 31356474
JAMA. 2018 Dec 4;320(21):2251-2259
pubmed: 30347031
Lancet Infect Dis. 2011 May;11(5):372-80
pubmed: 21420908
Pharmacoepidemiol Drug Saf. 2005 Jul;14(7):501-6
pubmed: 15844215
Am J Respir Crit Care Med. 2001 Jun;163(7):1584-90
pubmed: 11401878
Thorax. 2016 May;71(5):395-6
pubmed: 27055857
Clin Infect Dis. 2019 Jul 18;69(3):388-396
pubmed: 30358811
Trials. 2018 Feb 17;19(1):111
pubmed: 29452598
Lancet Infect Dis. 2011 Mar;11(3):208-22
pubmed: 21371655
Clin Infect Dis. 2019 Sep 13;69(7):1091-1098
pubmed: 30535100
Biometrics. 1979 Sep;35(3):549-56
pubmed: 497341
N Engl J Med. 2006 Dec 21;355(25):2619-30
pubmed: 17182987
Am J Med. 2013 Dec;126(12):1099-106
pubmed: 24262724
JAMA. 1994 May 25;271(20):1598-601
pubmed: 8182812
N Engl J Med. 1999 Feb 11;340(6):409-17
pubmed: 9971864
Clin Infect Dis. 2008 Feb 15;46(4):491-6
pubmed: 18194098
N Engl J Med. 2011 Apr 7;364(14):1305-14
pubmed: 21417952
Acta Med Scand. 1988;223(5):469-77
pubmed: 3287839
Nat Rev Drug Discov. 2006 Jan;5(1):27-36
pubmed: 16485344
Trials. 2020 Jan 15;21(1):92
pubmed: 31941546
Trials. 2015 Apr 18;16:173
pubmed: 25903783
Clin Infect Dis. 2005 Nov 15;41(10):1373-406
pubmed: 16231249
Can J Infect Dis. 2000 Mar;11(2):107-11
pubmed: 18159274
Arch Intern Med. 2003 Apr 28;163(8):972-8
pubmed: 12719208
Stat Biosci. 2018 Aug;10(2):439-459
pubmed: 30344778
Clin Infect Dis. 2019 Sep 13;69(7):1099-1100
pubmed: 30535118

Auteurs

Nick Daneman (N)

Division of Infectious Diseases & Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada Nick.Daneman@sunnybrook.ca.
ORCID: 0000-0001-8827-3764

Asgar H Rishu (AH)

Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Ruxandra L Pinto (RL)

Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Yaseen M Arabi (YM)

Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.

Deborah J Cook (DJ)

McMaster University, Hamilton, Ontario, Canada.

Richard Hall (R)

Departments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

Shay McGuinness (S)

Auckland City Hospital, Auckland, New Zealand.

John Muscedere (J)

Kingston General Hospital, Kingston, Ontario, Canada.

Rachael Parke (R)

The University of Auckland, Auckland, New Zealand.

Steven Reynolds (S)

Royal Columbian Hospital, New Westminster, British Columbia, Canada.

Benjamin Rogers (B)

Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Melborne, Victoria, Australia.

Yahya Shehabi (Y)

Critical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.

Robert A Fowler (RA)

Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

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