Evidence map›Paper›PMID 25136024›Full record

Trial reportAntimicrobial agents and chemotherapy2014

Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment.

S Flanagan, S L Minassian, D Morris, R Ponnuraj, T C Marbury, H W Alcorn, E Fang, P Prokocimer

2 registry-linked trialsOpen access · bronzeAbstract readClinical 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 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
6.5field-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.

NCT01431833 phase1completednot on this map

A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment

TypeinterventionalSponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2011 to 2012Enrolled32ConditionsHepatic ImpairmentArmsTR-701 FA
NCT01452828 phase1completednot on this map

A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects

TypeinterventionalSponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2011 to 2012Enrolled24ConditionsRenal ImpairmentArmsTR-701 FA single infusion, TR-701 FA
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 60 citations in OpenAlex.

  1. Review
  2. Review
  3. Pharmacology of emerging drugs for the treatment of multi-drug resistant tuberculosis.Journal of clinical tuberculosis and other mycobacterial diseases · 2024
    Review
  4. Article
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  7. Review
  8. Review
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  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Tedizolid Phosphate: a Next-Generation Oxazolidinone.Infectious diseases and therapy · 2015
    Article
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

8 authors at 5 institutions in 1 country.

S FlanaganCubist, San Diego, California, USA shawn.flanagan@cubist.com.
S L MinassianMinassian Biostatistics, Inc., San Diego, California, USA.
D MorrisCovance, Madison, Wisconsin, USA.
R PonnurajCovance, Madison, Wisconsin, USA.
T C MarburyOrlando Clinical Research Center, Orlando, Florida, USA.
H W AlcornDaVita Clinical Research, Minneapolis, Minnesota, USA.
E FangCubist, San Diego, California, USA.
P ProkocimerCubist, San Diego, California, USA.
Cubist Pharmaceuticals (United States) · USCovance (United States) · USBiostatistical Consulting (United States) · USDaVita Clinical Research (United States) · USOrlando Clinical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two open-label, single-dose, parallel-group studies were conducted to characterize the pharmacokinetics of the novel antibacterial tedizolid and the safety of tedizolid phosphate, its prodrug, in renally or hepatically impaired subjects. Tedizolid pharmacokinetics in subjects with severe renal impairment without dialysis support was compared with that of matched control subjects with normal renal function. Effects of hemodialysis on tedizolid pharmacokinetics were determined in a separate cohort of subjects undergoing long-term hemodialysis. Effects of hepatic impairment on tedizolid pharmacokinetics were determined in subjects with moderate or severe hepatic impairment and compared with those of matched control subjects with normal hepatic function. Each participant received a single oral (hepatic impairment) or intravenous (renal impairment) dose of tedizolid phosphate at 200 mg; hemodialysis subjects received two doses (separated by 7 days), before and after dialysis, in a crossover fashion. The pharmacokinetics of tedizolid was similar in subjects with severe renal impairment and controls (∼8% lower area under the concentration-time curve [AUC], with a nearly identical peak concentration) and in subjects undergoing hemodialysis before and after tedizolid phosphate administration (∼9% lower AUC, with a 15% higher peak concentration); <10% of the dose was removed during 4 h of hemodialysis. Tedizolid pharmacokinetics was only minimally altered in subjects with moderate or severe hepatic impairment; the AUC was increased approximately 22% and 34%, respectively, compared with that of subjects in the control group. Tedizolid phosphate was generally well tolerated in all participants. These results suggest that tedizolid phosphate dose adjustments are not necessary in patients with any degree of renal or hepatic impairment. (This study has been registered at ClinicalTrials.gov under registration numbers NCT01452828 [renal study] and NCT01431833 [hepatic study].).

Indexed as

AdolescentAdultAgedAnti-Bacterial AgentsArea Under CurveBacterial InfectionsCross-Over StudiesFemaleHumansKidneyKidney Failure, ChronicLiverLiver DiseasesMaleMiddle AgedOrganophosphatesAnti-Bacterial AgentsOrganophosphatesOxazolesOxazolidinonesProdrugstedizolidtedizolid phosphateTetrazoles

Identifiers

PMID25136024
PMCPMC4249404
OpenAlexW1992271563

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.