Evidence map›Paper›PMID 25246392›Full record

Trial reportAntimicrobial agents and chemotherapy2014

Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials.

Thomas P Lodise, Edward Fang, Sonia L Minassian, Philippe G Prokocimer

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2014. 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 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
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

23 citing papers in PubMed.

  1. Trial
  2. Efficacy, safety, tolerability and population pharmacokinetics of tedizolid, a novel antibiotic, in Latino patients with acute bacterial skin and skin structure infections.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. MDR Tuberculosis Treatment.Medicina (Kaunas, Lithuania) · 2022
    Review
  9. Review
  10. Article
  11. Article
  12. Myelosuppression with Oxazolidinones: Are There Differences?Antimicrobial agents and chemotherapy · 2019
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Thrombocytopenia with Tedizolid and Linezolid.Antimicrobial agents and chemotherapy · 2018
    Article
  18. Review
  19. Review
  20. Review
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

4 authors.

Thomas P LodiseAlbany College of Pharmacy and Health Sciences, Albany, New York, USA thomas.lodise@acphs.edu.
Edward FangClinical Development, Cubist Pharmaceuticals, San Diego, California, USA.
Sonia L MinassianMinassian Biostatistics, Inc., San Diego, California, USA.
Philippe G ProkocimerClinical Development, Cubist Pharmaceuticals, San Diego, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tedizolid, the active moiety of tedizolid phosphate, is a recently approved oxazolidinone antibacterial with activity against a wide range of Gram-positive pathogens, including resistant strains such as methicillin-resistant Staphylococcus aureus. To date, 6 days of 200 mg tedizolid once daily has been shown to be noninferior to 10 days of 600 mg linezolid twice daily in two randomized, double-blind phase 3 trials (ESTABLISH-1 and ESTABLISH-2) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). The intent of this study was to characterize the platelet profiles of patients receiving tedizolid relative to linezolid over the course of treatment using pooled data from these two trials. The occurrences of clinically defined and statistical analysis plan-specified reduced platelet counts were assessed at the study days 7 to 9 visit, the study days 11 to 13 visit, and the posttherapy evaluation (PTE) visit. At the study days 7 to 9 visit, incidences of reduced platelet counts were low and largely similar between the groups. The only notable difference was a lower incidence of thrombocytopenia (platelet counts, <150,000 cells/mm(3)) among patients who received tedizolid (3.2%) relative to those who received linezolid (5.6%). At the study days 11 to 13 visit, patients who received tedizolid had lower incidences of platelet counts of <150,000 cells/mm(3) (-5.9%), <112,500 cells/mm(3) (-2.4%), and <100,000 cells/mm(3) (-1.9%) than patients in the linezolid group. Similar differences were noted at the PTE visit. Findings across the two phase 3 ABSSSI trials suggest that 6 days of 200 mg tedizolid daily confers a low potential for reduced platelet counts among patients with ABSSSIs. (The ESTABLISH-1 and ESTABLISH-2 trials have been registered at ClinicalTrials.gov under registration numbers NCT01170221 and NCT01421511, respectively.).

Indexed as

AcetamidesAnti-Bacterial AgentsBlood PlateletsDouble-Blind MethodDrug Administration ScheduleHumansLinezolidMethicillin-Resistant Staphylococcus aureusOxazolidinonesPlatelet CountStaphylococcal Skin InfectionsTetrazolesAcetamidesAnti-Bacterial AgentsLinezolidOxazolidinonestedizolidTetrazoles

Identifiers

PMID25246392
PMCPMC4249542

What OpenQuestion holds

Textmetadata
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.