Evidence map›Paper›PMID 30242736›Full record

ArticleInfectious diseases and therapy2018

Efficacy and Safety of Tedizolid and Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Injection Drug Users: Analysis of Two Clinical Trials.

Gregory J Moran, Carisa De Anda, Anita F Das, Sinikka Green, Purvi Mehra, Philippe Prokocimer

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT01170221 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

TypeinterventionalSponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2010 to 2011Enrolled667ConditionsSkin and Subcutaneous Tissue Bacterial InfectionsArmsTR-701 FA, Linezolid
NCT01421511 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI

TypeinterventionalSponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2011 to 2013Enrolled666ConditionsSkin and Subcutaneous Tissue Bacterial InfectionsArmsTR-701 FA, Linezolid
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
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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

6 authors at 3 institutions in 1 country.

Gregory J MoranDivision of Infectious Diseases, Department of Emergency Medicine, Olive View-UCLA Medical Center, Sylmar, CA, USA.
Carisa De AndaMRL, Merck & Co., Inc., Kenilworth, NJ, USA. carisa.de.anda@merck.com.
Anita F DasDepartment of Biostatistics, InClin, San Mateo, CA, USA.
Sinikka GreeneStudySite, San Diego, CA, USA.
Purvi MehraArtemis Institute for Clinical Research, San Diego, CA, USA.
Philippe ProkocimerMRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USArtemis (United States) · USOlive View-UCLA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInjection drug users (IDUs) often develop acute bacterial skin and skin structure infections (ABSSSI) and use emergency departments as their primary source for medical care.

methodsA post hoc subgroup analysis of two randomized trials examined the efficacy and safety of tedizolid in the treatment of ABSSSI in IDUs. IDUs (n = 389) were identified from two pooled phase 3 trials (NCT01170221, NCT01421511) in patients with ABSSSI (n = 1333). Patients were randomly assigned to tedizolid phosphate (200 mg once daily, 6 days) or linezolid (600 mg twice daily, 10 days). Primary endpoint was ≥ 20% reduction in lesion area from baseline at 48 -72 h. Secondary endpoints included investigator-assessed clinical and microbiological response at the post-therapy evaluation (PTE).

resultsWound infection was more common in IDUs (52.2%), while cellulitis/erysipelas was more common in non-IDUs (55.9%). Most infections were due to Staphylococcus aureus (IDUs, 75.2%; non-IDUs, 85.6%), while oral pathogens were more prevalent in IDUs. Early clinical success rates for tedizolid and linezolid were 82.5% and 79.6% in IDUs and 81.3% and 79.3% for non-IDUs, respectively; responses at PTE were similar. Microbiological response per pathogen was similar between treatment groups. Rates of treatment-emergent adverse events (AEs) in IDUs were comparable between tedizolid (46.2%) and linezolid (47.8%) arms, while lower incidence of gastrointestinal AEs was observed with tedizolid (20.3%) than with linezolid (25.1%).

conclusionEfficacy and safety of tedizolid and linezolid in the treatment of ABSSSI was similar in IDUs and non-IDUs, supporting the use of oxazolidinones in treating ABSSSIs in IDUs.

fundingMerck & Co., Inc., Kenilworth, NJ, USA.

Indexed as

ABSSSIInjection drug userLinezolidTedizolid

Identifiers

PMID30242736
PMCPMC6249184
OpenAlexW2891699786

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.