Evidence map›Paper›PMID 37254156›Full record

Trial reportTrials2023

Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: statistical analysis plan for the BATCH trial and PRECISE sub-study.

Simon M Schoenbuchner, Chao Huang, Cherry-Ann Waldron, Emma Thomas-Jones, Kerenza Hood, Enitan D Carrol, Philip Pallmann

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. 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

7 authors at 3 institutions in 1 country.

Simon M SchoenbuchnerCentre for Trials Research, Cardiff University, Cardiff, UK. SchoenbuchnerSM@cardiff.ac.uk.
Chao HuangHull York Medical School, University of Hull, Hull, UK.
Cherry-Ann WaldronCentre for Trials Research, Cardiff University, Cardiff, UK.
Emma Thomas-JonesCentre for Trials Research, Cardiff University, Cardiff, UK.
Kerenza HoodCentre for Trials Research, Cardiff University, Cardiff, UK.
Enitan D CarrolInstitute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.
Philip PallmannCentre for Trials Research, Cardiff University, Cardiff, UK.
Cardiff University · GBHull York Medical School · GBUniversity of Liverpool · GB

Funding

Efficacy and Mechanism Evaluation Programme NIHR129960Health Technology Assessment Programme 15/188/42
6 · The paper itself

Abstract

introductionThe BATCH trial is a multi-centre randomised controlled trial to compare procalcitonin-guided management of severe bacterial infection in children with current management. PRECISE is a mechanistic sub-study embedded into the BATCH trial. This paper describes the statistical analysis plan for the BATCH trial and PRECISE sub-study.

methodsThe BATCH trial will assess the effectiveness of an additional procalcitonin test in children (aged 72 h to 18 years) hospitalised with suspected or confirmed bacterial infection to guide antimicrobial prescribing decisions. Participants will be enrolled in the trial from randomisation until day 28 follow-up. The co-primary outcomes are duration of intravenous antibiotic use and a composite safety outcome. Target sample size is 1942 patients, based on detecting a 1-day reduction in intravenous antibiotic use (90% power, two-sided) and on a non-inferiority margin of 5% risk difference in the composite safety outcome (90% power, one-sided), while allowing for up to 10% loss to follow-up.

resultsBaseline characteristics will be summarised overall, by trial arm, and by whether patients were recruited before or after the pause in recruitment due to the COVID-19 pandemic. In the primary analysis, duration of intravenous antibiotic use will be tested for superiority using Cox regression, and the composite safety outcome will be tested for non-inferiority using logistic regression. The intervention will be judged successful if it reduces the duration of intravenous antibiotic use without compromising safety. Secondary analyses will include sensitivity analyses, pre-specified subgroup analyses, and analysis of secondary outcomes. Two sub-studies, including PRECISE, involve additional pre-specified subgroup analyses. All analyses will be adjusted for the balancing factors used in the randomisation, namely centre and patient age.

conclusionWe describe the statistical analysis plan for the BATCH trial and PRECISE sub-study, including definitions of clinical outcomes, reporting guidelines, statistical principles, and analysis methods. The trial uses a design with co-primary superiority and non-inferiority endpoints. The analysis plan has been written prior to the completion of follow-up.

trial registrationBATCH: ISRCTN11369832, registered 20 September 2017, doi.org/10.1186/ISRCTN11369832. PRECISE: ISRCTN14945050, registered 17 December 2020, doi.org/10.1186/ISRCTN14945050.

Indexed as

Bacterial InfectionsCOVID-19Anti-Bacterial AgentsBiomarkersChildHumansPandemicsProcalcitoninTreatment OutcomeAnti-Bacterial AgentsBiomarkersProcalcitoninAntimicrobial stewardshipHospitalised childrenProcalcitoninRandomised controlled trialSevere bacterial infectionStatistical analysis plan

Identifiers

PMID37254156
PMCPMC10227801
OpenAlexW4378781942

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.