Evidence map›Paper›PMID 31941546›Full record

Trial reportTrials2020

A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards.

Nick Daneman, Asgar H Rishu, Ruxandra Pinto, Yaseen Arabi, Emilie P Belley-Cote, Robert Cirone, Mark Downing, Deborah J Cook, Richard Hall, Shay McGuinness and 10 more

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

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02917551 (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness- BALANCE on the Wards), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

NCT02917551 nacompletednot on this map

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness- BALANCE on the Wards: A Pilot RCT

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2016 to 2020Enrolled134ConditionsBacteremiaArms7 days of adequate antibiotic treatment, 14 days of adequate antibiotic treatment
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

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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

20 authors at 10 institutions in 4 countries.

Nick DanemanDivision of Infectious Diseases & Clinical Epidemiology, Department of Medicine Sunnybrook Health Sciences Centre, University of Toronto and Adjunct Scientist, Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. nick.daneman@sunnybrook.ca.
Asgar H RishuDepartment of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, ON, Canada.
Ruxandra PintoDepartment of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, ON, Canada.
Yaseen ArabiCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Kingdom of Saudi Arabia.
Emilie P Belley-CoteDivision of Cardiology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Robert CironeDivision of Critical Care, St. Joseph's Health Centre, Toronto, ON, Canada.
Mark DowningDivision of Infectious Diseases, St. Joseph's Health Centre, Toronto, ON, Canada.
Deborah J CookDivision of Critical Care Medicine, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Richard HallDepartments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.
Shay McGuinnessCardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.
Lauralyn McIntyreDivision of Critical Care, Department of Medicine, The Ottawa Hospital, Ottawa, ON, Canada.
John MuscedereDepartment of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
Rachael ParkeCardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.
Steven ReynoldsDepartment of Biophysiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.
Benjamin A RogersCentre for Inflammatory Diseases, Monash University School of Clinical Sciences, Clayton, Victoria, Australia; Monash Infectious Diseases, Monash Health, Clayton, VIC, Australia.
Yahya ShehabiCritical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Clayton, Victoria, Australia and the Clinical School of Medicine, University of New South Wales, Randwick, NSW, Australia.
Phillip ShinDepartment of Medicine and Critical Care, North York General Hospital, Toronto, ON, Canada.
Richard WhitlockDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
Robert A FowlerDepartments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Center, Adjunct Scientist, Institute for Clinical Evaluative Sciences, Institute of Health Policy, Management and Evaluation, University of Toronto, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. rob.fowler@sunnybrook.ca.
Canadian Critical Care Trials Group
Sunnybrook Health Science Centre · CASt Joseph's Health Centre · CADalhousie University · CANorth York General Hospital · CAUniversity of Auckland · NZKing Saud bin Abdulaziz University for Health Sciences · SAMonash Medical Centre · AUOttawa Hospital · CAQueen's University · CASimon Fraser University · CA

Funding

Canadian Frailty Network CAT2017-08Canadian Institute of Health research 410006728Ontario Ministry of Health and Long-Term Care NA
6 · The paper itself

Abstract

backgroundThe optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards.

methodsWe conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients.

resultsA total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1-4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients.

conclusionIt is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results.

trial registrationClinicaltrials.gov, NCT02917551. Registered on September 28, 2016.

Indexed as

AgedAged, 80 and overAnti-Bacterial AgentsBacteremiaCase-Control StudiesClinical ProtocolsComorbidityFeasibility StudiesFemaleHumansIntensive Care UnitsMaleMiddle AgedMortalityTime FactorsTreatment OutcomeAnti-Bacterial AgentsBacteremiaBloodstream infectionCritical careDuration of treatmentIntensive care

Identifiers

PMID31941546
PMCPMC6964073
OpenAlexW2999924105

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.