Evidence map›Paper›PMID 22247123›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study.

Richard G Wunderink, Michael S Niederman, Marin H Kollef, Andrew F Shorr, Mark J Kunkel, Alice Baruch, William T McGee, Arlene Reisman, Jean Chastre

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02019420 (A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia), which is not on this map. Cited by 211 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 10 pooled it
40.0field-weighted citation impact, top 1% 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.

NCT02019420 phase3completednot on this mapstarted 2014, after this paper: background citation

A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia

TypeinterventionalSponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2014 to 2018Enrolled726ConditionsPneumoniaArmsTedizolid phosphate, Linezolid
3 · Its place in the literature

Who cites it

211 citing papers in PubMed, 10 syntheses or guidelines pooled it, 570 citations in OpenAlex.

  1. Linezolid-associated serotonin toxicity: a systematic review.European journal of clinical pharmacology · 2023
    Pooled it
  2. Vancomycin Area Under the Curve and Acute Kidney Injury: A Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
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  7. Assessment of bias in outcomes reported in trials on pneumonia: a systematic review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2014
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  8. Linezolid versus vancomycin or teicoplanin for nosocomial pneumonia: meta-analysis of randomised controlled trials.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2013
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151 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 2 countries.

Richard G WunderinkDepartment of Pulmonary and Critical Care, Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, USA. r-wunderink@northwestern.edu
Michael S Niederman
Marin H Kollef
Andrew F Shorr
Mark J Kunkel
Alice Baruch
William T McGee
Arlene Reisman
Jean Chastre
Pfizer (United States) · USMedStar Washington Hospital Center · USNorthwestern University · USSorbonne Université · FRTufts University · USWashington University in St. Louis · USWinthrop-University Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPost hoc analyses of clinical trial data suggested that linezolid may be more effective than vancomycin for treatment of methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia. This study prospectively assessed efficacy and safety of linezolid, compared with a dose-optimized vancomycin regimen, for treatment of MRSA nosocomial pneumonia.

methodsThis was a prospective, double-blind, controlled, multicenter trial involving hospitalized adult patients with hospital-acquired or healthcare-associated MRSA pneumonia. Patients were randomized to receive intravenous linezolid (600 mg every 12 hours) or vancomycin (15 mg/kg every 12 hours) for 7-14 days. Vancomycin dose was adjusted on the basis of trough levels. The primary end point was clinical outcome at end of study (EOS) in evaluable per-protocol (PP) patients. Prespecified secondary end points included response in the modified intent-to-treat (mITT) population at end of treatment (EOT) and EOS and microbiologic response in the PP and mITT populations at EOT and EOS. Survival and safety were also evaluated.

resultsOf 1184 patients treated, 448 (linezolid, n = 224; vancomycin, n = 224) were included in the mITT and 348 (linezolid, n = 172; vancomycin, n = 176) in the PP population. In the PP population, 95 (57.6%) of 165 linezolid-treated patients and 81 (46.6%) of 174 vancomycin-treated patients achieved clinical success at EOS (95% confidence interval for difference, 0.5%-21.6%; P = .042). All-cause 60-day mortality was similar (linezolid, 15.7%; vancomycin, 17.0%), as was incidence of adverse events. Nephrotoxicity occurred more frequently with vancomycin (18.2%; linezolid, 8.4%).

conclusionsFor the treatment of MRSA nosocomial pneumonia, clinical response at EOS in the PP population was significantly higher with linezolid than with vancomycin, although 60-day mortality was similar.

Indexed as

AcetamidesAdultAgedAnti-Bacterial AgentsCross InfectionFemaleHumansLinezolidMaleMethicillin-Resistant Staphylococcus aureusMiddle AgedOxazolidinonesPneumonia, StaphylococcalTreatment OutcomeAcetamidesAnti-Bacterial AgentsLinezolidOxazolidinones

Identifiers

PMID22247123
OpenAlexW2125096244

What OpenQuestion holds

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Read underepoch 390

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.