Evidence map›Paper›PMID 38943201›Full record

ArticleTrials2024

Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia-a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial.

Lydia Flett, Radwa Abdelatif, Sarah Akhtar Baz, Samantha Brady, Belén Corbacho, Kate Common, Abbie Cowling, Caroline Fairhurst, Ellie Fitzmaurice, Shreyans Gandhi and 16 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

26 authors.

Lydia FlettDepartment of Health Sciences, University of York, York, UK. Lydia.flett@york.ac.uk.ORCID http://orcid.org/0000-0002-8280-826X
Radwa AbdelatifDepartment of Health Sciences, University of York, York, UK.
Sarah Akhtar BazDepartment of Health Sciences, University of York, York, UK.
Samantha BradyDepartment of Health Sciences, University of York, York, UK.
Belén CorbachoDepartment of Health Sciences, University of York, York, UK.
Kate CommonPatient and Public Involvement, University of York, York, UK.
Abbie CowlingDepartment of Health Sciences, University of York, York, UK.
Caroline FairhurstDepartment of Health Sciences, University of York, York, UK.
Ellie FitzmauriceDepartment of Health Sciences, University of York, York, UK.
Shreyans GandhiKing's College Hospital NHS Foundation Trust, London, UK.
Andrea HiltonFaculty of Health Sciences, University of Hull, Hull, UK.
William HopeDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Alex HowardFaculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.
Joanne LaycockDepartment of Health Sciences, University of York, York, UK.
Patrick LillieHull University Teaching Hospitals NHS Trust, Hull, UK.
Gemma MitchellInstitute for Social Marketing and Health, University of Stirling, Stirling, UK.
Adwoa ParkerDepartment of Health Sciences, University of York, York, UK.
Mary PeelPatient and Public Involvement, University of York, York, UK.
Laura SheardDepartment of Health Sciences, University of York, York, UK.
Jacqueline SneddonBritish Society for Antimicrobial Chemotherapy, Birmingham, UK.
Thomas TayntonHull University Teaching Hospitals NHS Trust, Hull, UK.
Puvan TharmanathanDepartment of Health Sciences, University of York, York, UK.
David TorgersonDepartment of Health Sciences, University of York, York, UK.
Han-I WangDepartment of Health Sciences, University of York, York, UK.
David Allsup *Biomedical Institute for Multimorbidity, Hull York Medical School, University of Hull, Hull, UK.
Gavin Barlow *Department of Experimental Medicine & Biomedicine, Hull York Medical School, University of York, York, UK.

Funding

Health Technology Assessment Programme NIHR132674
6 · The paper itself

Abstract

backgroundAcute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and β-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing).

methodsBioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC). The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking. The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed. DISCUSSION: The BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship.

trial registrationISRCTN11633399. Registered 24/06/2022.

Indexed as

Antifungal AgentsBiomarkersCost-Benefit AnalysisInvasive Fungal InfectionsMulticenter Studies as TopicRandomized Controlled Trials as TopicAntimicrobial Stewardshipbeta-GlucansCost-Effectiveness AnalysisGalactoseHumansLeukemiaMannansTime FactorsTreatment OutcomeAntifungal Agentsbeta-GlucansBiomarkersgalactomannanGalactoseMannansAcute leukaemiaAntifungal stewardshipApergillosisBeta-D-GlucanGalactomannanInvasive fungal infection

Identifiers

PMID38943201
PMCPMC11214238

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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.