Evidence map›Paper›PMID 29180524›Full record

Trial reportAntimicrobial agents and chemotherapy2018

Safety and Pharmacokinetics of the Aminomethylcycline Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple-Dose Regimens.

Lu Ann Bundrant, Evan Tzanis, Lynne Garrity-Ryan, Stephen Bai, Surya Chitra, Amy Manley, Stephen Villano

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
1.6field-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.

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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Investigating the immunomodulatory activities of omadacycline.The Journal of antimicrobial chemotherapy · 2022
    Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Antimicrobial agents and chemotherapy · 2021
    Article
  14. Article
  15. Review
  16. Omadacycline for the Treatment ofOpen forum infectious diseases · 2020
    Article
  17. Article
  18. Review
  19. Review
  20. Pharmacokinetics and Pharmacodynamics of Oral and Intravenous Omadacycline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    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

7 authors at 1 institution in 1 country.

Lu Ann BundrantPPD Phase I Clinic, Austin, Texas, USA.
Evan TzanisParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Lynne Garrity-RyanParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA Lynne.Garrity-Ryan@ParatekPharma.com.
Stephen BaiParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Surya ChitraParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Amy ManleyParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Stephen VillanoParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Paratek Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Omadacycline, a first-in-class aminomethylcycline antibiotic, is related to tetracyclines but is structurally modified to circumvent mechanisms of resistance to tetracyclines. Omadacycline demonstrates potent activity against a broad range of pathogens, including drug-resistant strains, and is in late-stage development for treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Previous studies support an intravenous-to-oral transition regimen with 300-mg once-daily oral dosing. This phase 1 study investigated the pharmacokinetics and safety/tolerability of multiple oral omadacycline doses higher than 300 mg. Using a 3-period crossover design, healthy adults were randomized to receive oral omadacycline at 300, 450, and 600 mg in variable sequence (

Indexed as

Administration, OralAdolescentAdultAnti-Bacterial AgentsArea Under CurveDouble-Blind MethodDrug Administration ScheduleDrug Dosage CalculationsFemaleHealthy VolunteersHumansMaleMiddle AgedPatient SafetyTetracyclinesAnti-Bacterial AgentsomadacyclineTetracyclinesmultidose regimenomadacyclineoral dosing

Identifiers

PMID29180524
PMCPMC5786815
OpenAlexW2768638529

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.