Evidence map›Paper›PMID 24732289›Full record

Trial reportPloS one2014

Mycobactericidal activity of sutezolid (PNU-100480) in sputum (EBA) and blood (WBA) of patients with pulmonary tuberculosis.

Robert S Wallis, Rodney Dawson, Sven O Friedrich, Amour Venter, Darcy Paige, Tong Zhu, Annette Silvia, Jason Gobey, Craig Ellery, Yao Zhang and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01225640 (A Phase 2a, Open-Label, Randomized Study In Treatment-Naive, Sputum Smear Positive Subjects With Drug-Sensitive Pulmonary Tuberculosis To Assess Early Bactericidal Activity), which is not on this map. Cited by 75 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 3 pooled it
7.7field-weighted citation impact, top 2% 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.

NCT01225640 phase2completednot on this map

A Phase 2a, Open-Label, Randomized Study In Treatment-Naive, Sputum Smear Positive Subjects With Drug-Sensitive Pulmonary Tuberculosis To Assess Early Bactericidal Activity (EBA) And Whole Blood Activity (WBA) Of PNU-100480 (PF-02341272)

TypeinterventionalSponsorSequella, Inc.Ran2011 to 2011Enrolled59ConditionsTuberculosisArmsPNU-100480, RHZE
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 3 syntheses or guidelines pooled it, 163 citations in OpenAlex.

  1. Pooled it
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  12. Review
  13. New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025
    Review
  14. Mechanism, Efficacy, and Safety of Natural Antibiotics.Antibiotics (Basel, Switzerland) · 2025
    Review
  15. Article
  16. Improved Radiosynthesis of [ACS infectious diseases · 2025
    Article
  17. Article
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  19. Article
  20. Review

15 more citing papers are in PubMed but not listed here.

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

13 authors at 5 institutions in 2 countries.

Robert S WallisFormerly Pfizer Inc, Groton, Connecticut, United States of America.
Rodney DawsonUniversity of Cape Town, Cape Town, South Africa.
Sven O FriedrichDivision of Medical Physiology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Amour VenterMedical Research Council Centre for Molecular and Cellular Biology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Darcy PaigePfizer, Groton, Connecticut, United States of America.
Tong ZhuPfizer, Groton, Connecticut, United States of America.
Annette SilviaPfizer, Groton, Connecticut, United States of America.
Jason GobeyPfizer, Groton, Connecticut, United States of America.
Craig ElleryPfizer, Groton, Connecticut, United States of America.
Yao ZhangPfizer, Groton, Connecticut, United States of America.
Kathleen EisenachUniversity of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America.
Paul MillerFormerly Pfizer Inc, Groton, Connecticut, United States of America.
Andreas H DiaconDivision of Medical Physiology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Pfizer (United States) · USStellenbosch University · ZASouth African Medical Research Council · ZAUniversity of Arkansas for Medical Sciences · USUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleSutezolid (PNU-100480) is a linezolid analog with superior bactericidal activity against Mycobacterium tuberculosis in the hollow fiber, whole blood and mouse models. Like linezolid, it is unaffected by mutations conferring resistance to standard TB drugs. This study of sutezolid is its first in tuberculosis patients.

methodsSputum smear positive tuberculosis patients were randomly assigned to sutezolid 600 mg BID (N = 25) or 1200 mg QD (N = 25), or standard 4-drug therapy (N = 9) for the first 14 days of treatment. Effects on mycobacterial burden in sputum (early bactericidal activity or EBA) were monitored as colony counts on agar and time to positivity in automated liquid culture. Bactericidal activity was also measured in ex vivo whole blood cultures (whole blood bactericidal activity or WBA) inoculated with M. tuberculosis H37Rv.

resultsAll patients completed assigned treatments and began subsequent standard TB treatment according to protocol. The 90% confidence intervals (CI) for bactericidal activity in sputum over the 14 day interval excluded zero for all treatments and both monitoring methods, as did those for cumulative WBA. There were no treatment-related serious adverse events, premature discontinuations, or dose reductions due to laboratory abnormalities. There was no effect on the QT interval. Seven sutezolid-treated patients (14%) had transient, asymptomatic ALT elevations to 173±34 U/L on day 14 that subsequently normalized promptly; none met Hy's criteria for serious liver injury.

conclusionsThe mycobactericidal activity of sutezolid 600 mg BID or 1200 mg QD was readily detected in sputum and blood. Both schedules were generally safe and well tolerated. Further studies of sutezolid in tuberculosis treatment are warranted.

trial registrationClinicalTrials.gov NCT01225640.

Indexed as

AdultAlanine TransaminaseAnimalsBlood Bactericidal ActivityColony Count, MicrobialFemaleHumansMaleMiceMicrobial Sensitivity TestsMycobacterium tuberculosisOxazolidinonesSputumTuberculosis, PulmonaryAlanine TransaminaseOxazolidinonesPNU-100480

Identifiers

PMID24732289
PMCPMC3986205
OpenAlexW2045132255

What OpenQuestion holds

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LicenceCC BY
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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.