Evidence map›Paper›PMID 37369422›Full record

ArticleBMJ open2023

Non-inferiority trial of a shorter (7 days) compared with a longer (14 days) duration of antimicrobial therapy for the treatment of bacteraemic urinary sepsis, measured by microbiological success after the completion of therapy: a substudy protocol for the Bacteraemia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) multicentre randomised controlled trial.

Benjamin A Rogers, Robert Fowler, Patrick N A Harris, Joshua S Davis, Ruxandra L Pinto, Dhiraj Bhatia Dwivedi, Asgar Rishu, Yahya Shehabi, Nick Daneman

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03005145 (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% 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.

NCT03005145 nacompletednot on this map

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: Randomized Controlled Trial

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2017 to 2023Enrolled3,622ConditionsBacteremia, Intensive Care, Critically Ill, SepsisArms7 days of adequate antibiotic treatment, 14 days of adequate antibiotic treatment.
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
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

9 authors at 5 institutions in 2 countries.

Benjamin A RogersSchool of Clinical Sciences at Monash Health, Faculty of Medicine Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia Ben.Rogers@monash.edu.ORCID 0000-0001-6515-2118
Robert FowlerSunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Patrick N A HarrisUQ Centre for Clinical Research, Faculty of Medicine, University of Queensland, Herston, Queensland, Australia.
Joshua S DavisSchool of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.
Ruxandra L PintoDepartment of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Dhiraj Bhatia DwivediSchool of Clinical Sciences at Monash Health, Faculty of Medicine Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.
Asgar RishuSunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Yahya ShehabiSchool of Clinical Sciences at Monash Health, Faculty of Medicine Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.
Nick DanemanDivision of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0001-8827-3764
Sunnybrook Health Science Centre · CAMonash Health · AUThe University of Queensland · AUUniversity of Newcastle Australia · AUUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe BALANCE study is a randomised clinical trial (3626 participants) designed to assess the non-inferiority of 7 days (short-course) antibiotic therapy compared with 14 days of therapy for bacteraemia using the pragmatic endpoint of 90-day survival. Based on pilot study data, approximately 30% of enrolees will have a urinary tract infection (UTI) as the source of bacteraemia. METHODS AND ANALYSIS: We aim to assess the non-inferiority of short-course antibiotic therapy for patients with bacteraemia UTIs.Participating sites in four countries will be invited to join this substudy. All participants of this substudy will be enrolled in the main BALANCE study. The intervention will be assigned and treatment administered as specified in the main protocol.We will include participants in this substudy if the probable source of their infection is a UTI, as judged by the site principal investigator, and they have a urine microscopy and culture indicative of a UTI. Participants will be excluded if they have an ileal loop, vesicoureteric reflux or suspected or confirmed prostatitis.The primary outcome is the absence of a positive culture on a test-of-cure urine sample collected 6-12 days after cessation of antimicrobials, with a non-inferiority margin of 15%. Secondary outcomes include the clinical resolution of infection symptoms at test-of-cure. ETHICS AND DISSEMINATION: The study has been approved in conjunction with the main BALANCE study through the relevant ethics review process at each participating site. We will disseminate the results through the Australasian Society for Infectious Diseases, Canadian Critical Care Trials Group, the Association for Medical Microbiology and Infectious Diseases Canada Clinical Research Network (AMMI Canada CRN) and other collaborators. UNIVERSAL TRIAL NUMBER: U1111-1256-0874. MAIN BALANCE

trial registrationNCT03005145. TRIAL REGISTRATION NUMBER: Australian Clinical Trial Register: ACTRN12620001108909.

Indexed as

BacteremiaCommunicable DiseasesSepsisUrinary Tract InfectionsAnti-Bacterial AgentsAustraliaCanadaEquivalence Trials as TopicHumansMaleMicroscopyMulticenter Studies as TopicPilot ProjectsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeAnti-Bacterial Agentsclinical trialsinfectious diseasesintensive & critical careurinary tract infections

Identifiers

PMID37369422
PMCPMC10410794
OpenAlexW4382344637

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.