Evidence map›Paper›PMID 37874021›Full record

SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

The Safety and Tolerability of Linezolid in Novel Short-Course Regimens Containing Bedaquiline, Pretomanid, and Linezolid to Treat Rifampicin-Resistant Tuberculosis: An Individual Patient Data Meta-analysis.

Tasnim Hasan, Ellie Medcalf, Bern-Thomas Nyang'wa, Erica Egizi, Catherine Berry, Matthew Dodd, Salah Foraida, Medea Gegia, Mengchun Li, Fuad Mirzayev and 6 more

Open access · hybridAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
6.2field-weighted citation impact, top 3% 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

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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  4. Bedaquiline and linezolid regimens for multidrug-resistant tuberculosis: a systematic review and meta-analysis.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2025
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  19. New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025
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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

16 authors at 5 institutions in 5 countries.

Tasnim HasanFaculty of Medicine and Health, University of Sydney, Sydney, Australia.ORCID 0000-0001-6407-8155
Ellie MedcalfFaculty of Medicine and Health, University of Sydney, Sydney, Australia.
Bern-Thomas Nyang'waPublic Health Department, Médecins sans Frontières, Amsterdam, The Netherlands.
Erica EgiziTB Alliance Research and Development, New York City, USA.
Catherine BerryManson Unit, Médecins sans Frontières, London, United Kingdom.
Matthew DoddDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Salah ForaidaTB Alliance Research and Development, New York City, USA.
Medea GegiaGlobal Tuberculosis Program, World Health Organization, Geneva, Switzerland.
Mengchun LiTB Alliance Research and Development, New York City, USA.
Fuad MirzayevGlobal Tuberculosis Program, World Health Organization, Geneva, Switzerland.
Hannah MorganFaculty of Medicine and Health, University of Sydney, Sydney, Australia.
Ilaria MottaManson Unit, Médecins sans Frontières, London, United Kingdom.
Linh NguyenGlobal Tuberculosis Program, World Health Organization, Geneva, Switzerland.
Samuel SchumacherGlobal Tuberculosis Program, World Health Organization, Geneva, Switzerland.
Tim SchlubFaculty of Medicine and Health, University of Sydney, Sydney, Australia.
Greg FoxFaculty of Medicine and Health, University of Sydney, Sydney, Australia.
The University of Sydney · AUWorld Health Organization · CHTB Alliance · USLondon School of Hygiene & Tropical Medicine · GBMédecins Sans Frontières‎ · GB

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundEffectiveness, safety, tolerability, and adherence are critical considerations in shifting to shorter tuberculosis (TB) regimens. Novel 6-month oral regimens that include bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without a fourth drug, have been shown to be as or more effective than the established longer regimens for the treatment of multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB). We aimed to evaluate the safety and tolerability of linezolid in BPaL-containing regimens for the treatment of MDR/RR-TB among recently completed clinical trials.

methodsA review and meta-analysis was undertaken including published and unpublished data from clinical trials, conducted between 2010 and 2021, that evaluated regimens containing BPaL for the treatment of MDR/RR-TB. Individual patient data were obtained. For each BPaL-containing regimen, we evaluated the frequency and severity of treatment-related adverse events. The risk difference of adverse events for each regimen was calculated, in comparison to patients assigned to receiving the lowest cumulative exposure of linezolid.

resultsData from 3 clinical trials investigating 8 unique BPaL-containing regimens were included, comprising a total of 591 participants. Adverse events were more frequent in groups randomized to a higher cumulative linezolid dose. Among patients who were randomized to a daily dose of 1200 mg linezolid, 68 of 195 (35%) experienced a grade 3-4 adverse event versus 89 of 396 (22%) patients receiving BPaL-containing regimens containing 600 mg linezolid.

conclusionsRegimens containing BPaL were relatively well tolerated when they included a daily linezolid dose of 600 mg. These novel regimens promise to improve the tolerability of treatment for MDR/RR-TB.

Indexed as

LinezolidTuberculosisTuberculosis, Multidrug-ResistantAntitubercular AgentsDiarylquinolinesHumansNitroimidazolesRandomized Controlled Trials as TopicRifampinAntitubercular AgentsbedaquilineDiarylquinolinesLinezolidNitroimidazolespretomanidRifampinBPaLlinezolidmultidrug-resistant tuberculosissevere adverse events

Identifiers

PMID37874021
PMCPMC10954324
OpenAlexW4387892934

What OpenQuestion holds

Textmetadata
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.