Evidence map›Paper›PMID 38462751›Full record

Trial reportExpert opinion on drug safety2024

T-wave morphology abnormalities in the STREAM stage 1 trial.

Gareth Hughes, William J Young, Henry Bern, Angela Crook, Pier D Lambiase, Ruth L Goodall, Andrew J Nunn, Sarah K Meredith

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Expert opinion on drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02409290 (STREAM), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 95% 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.

NCT02409290 phase3completednot on this map

STREAM: The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

TypeinterventionalSponsorIUATLD, IncRan2016 to 2023Enrolled588ConditionsMDR-TBArmsRegimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine, Ethambutol, Pyrazinamide
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

8 authors at 3 institutions in 1 country.

Gareth HughesMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
William J YoungCentre for Clinical Pharmacology and Precision Medicine, William Harvey Research Institute, Queen Mary University of London, London, UK.
Henry BernMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
Angela CrookMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
Pier D LambiaseInstitute of Cardiovascular Science, University College London, London, UK.
Ruth L GoodallMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
Andrew J NunnMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
Sarah K MeredithMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
MRC Clinical Trials Unit at UCL · GBUniversity College London · GBWilliam Harvey Research Institute · GB

Funding

Medical Research Council MC_UU_12023/26Medical Research Council MR/J012513/1
6 · The paper itself

Abstract

backgroundShorter regimens for drug-resistant tuberculosis (DR-TB) have non-inferior efficacy compared with longer regimens, but QT prolongation is a concern. T-wave morphology abnormalities may be a predictor of QT prolongation. RESEARCH DESIGN AND

methodsSTREAM Stage 1 was a randomized controlled trial in rifampicin-resistant TB, comparing short and long regimens. All participants had regular ECGs. QT/QTcF prolongation (≥500 ms or increase in ≥60 ms from baseline) was more common on the short regimen which contained high-dose moxifloxacin and clofazimine. Blinded ECGs were selected from the baseline, early (weeks 1-4), and late (weeks 12-36) time points. T-wave morphology was categorized as normal or abnormal (notched, asymmetric, flat-wave, flat peak, or broad). Differences between groups were assessed using Chi-Square tests (paired/unpaired, as appropriate).

resultsTwo-hundred participants with available ECGs at relevant times were analyzed (QT prolongation group

conclusionsT-wave abnormalities may help identify patients at risk of QT prolongation on DR-TB treatment.

trial registrationThe trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02409290). Current Controlled Trial number, ISRCTN78372190.

Indexed as

Long QT SyndromeTuberculosis, Multidrug-ResistantArrhythmias, CardiacElectrocardiographyHumansMoxifloxacinMoxifloxacinclofazimineelectrocardiogrammoxifloxacinQTcFRifampicin-resistant tuberculosisT wave morphology

Identifiers

PMID38462751
PMCPMC11761056
OpenAlexW4392656236

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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.