Evidence map›Paper›PMID 24989138›Full record

Trial reportPharmacotherapy2014

Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid.

Shawn Flanagan, Edward Fang, Kelly A Muñoz, Sonia L Minassian, Philippe G Prokocimer

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Pharmacotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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
  4. Circadian considerations in antimicrobials.European journal of clinical pharmacology · 2026
    Review
  5. Review
  6. Pharmacology of emerging drugs for the treatment of multi-drug resistant tuberculosis.Journal of clinical tuberculosis and other mycobacterial diseases · 2024
    Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Importance and Reality of TDM for Antibiotics Not Covered by Insurance in Japan.International journal of environmental research and public health · 2022
    Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

5 authors.

Shawn FlanaganCubist, San Diego, California.
Edward Fang
Kelly A Muñoz
Sonia L Minassian
Philippe G Prokocimer

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTedizolid phosphate is a novel antibacterial under investigation for the treatment of gram-positive infections. This study was conducted to assess the pharmacokinetics, safety, and tolerability of intravenous tedizolid phosphate as well as the oral bioavailability of tedizolid phosphate.

designDouble-blind, single-ascending dose, multiple-dose pharmacokinetics study, as well as tolerability and open-label crossover studies.

settingSingle center in the United States (Covance Clinical Research Unit, Madison, WI) between September 2009 and January 2010.

participantsNinety healthy volunteers.

interventionSingle intravenous (IV) doses of tedizolid phosphate 50 mg (lead-in) and 100-400 mg. Single oral and IV dose of tedizolid phosphate 200 mg in crossover fashion. Multiple IV doses of tedizolid phosphate 200 and 300 mg for up to 7 days. MEASUREMENTS AND MAIN

resultsA dose-dependent increase was observed in the maximum plasma concentration (1.2-5.1 μg/ml) and the area under the concentration-time curve (17.4-58.7 μg × hr/ml) of tedizolid (the microbiologically active moiety of tedizolid phosphate) after single IV doses of tedizolid phosphate 100-400 mg. Administration of IV tedizolid phosphate 200 mg once/day for 7 days resulted in minimal (28%) tedizolid accumulation. The absolute oral bioavailability of tedizolid after a single 200-mg dose of tedizolid phosphate was 91%; pharmacokinetic parameters of tedizolid were similar with oral and IV administration. Treatment-related adverse events occurred in 41% of subjects. Most adverse events were related to infusion site and became more frequent with multiple dosing. In an additional 3-day tolerability study, IV tedizolid phosphate 200 mg and placebo were similarly tolerated, based on visual infusion phlebitis scores.

conclusionThese results from a population of healthy volunteers support once/day dosing of tedizolid phosphate 200 mg with both the oral and IV formulations, without the need for dose adjustment when switching administration routes.

Indexed as

Administration, OralAdultAnti-Bacterial AgentsBiological AvailabilityCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansInjections, IntravenousMaleOrganophosphatesOxazolesPilot ProjectsYoung AdultAnti-Bacterial AgentsOrganophosphatesOxazolestedizolid phosphateintravenouspharmacokineticstedizolid phosphate

Identifiers

PMID24989138
PMCPMC4260119

What OpenQuestion holds

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Registered trials

None linked

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.