Evidence map›Paper›PMID 30349845›Full record

ArticleOpen forum infectious diseases2018

Safety of Delafloxacin: Focus on Adverse Events of Special Interest.

Thomas Lodise, Ralph Corey, David Hooper, Sue Cammarata

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

Article in Open forum infectious diseases, 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 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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.

NCT01811732 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections

TypeinterventionalSponsorMelinta Therapeutics, Inc.Ran2013 to 2014Enrolled660ConditionsSkin and Subcutaneous Tissue Bacterial InfectionsArmsDelafloxacin, Vancomycin, Aztreonam, Placebo
NCT01984684 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

TypeinterventionalSponsorMelinta Therapeutics, Inc.Ran2014 to 2016Enrolled850ConditionsSkin and Subcutaneous Tissue Bacterial Infections, Skin Structures and Soft Tissue InfectionsArmsdelafloxacin, vancomycin, aztreonam
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Analysis of Pooled Phase 3 Safety Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Trial
  3. Review
  4. Article
  5. Delafloxacin: what does a new fluoroquinolone offer?Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Delafloxacin for the Treatment of Acute Bacterial Skin and Skin Structure Infections.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 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

4 authors at 4 institutions in 1 country.

Thomas LodiseAlbany College of Pharmacy and Health Sciences, Albany, New York.
Ralph CoreyDuke University School of Medicine, Durham, North Carolina.
David HooperMassachusetts General Hospital, Boston, Massachusetts.
Sue CammarataMelinta Therapeutics, Lincolnshire, Illinois.ORCID 0000-0002-3796-807X
Albany College of Pharmacy and Health Sciences · USDuke University · USMassachusetts General Hospital · USMelinta Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFluoroquinolones have been widely used for a variety of Gram-positive and Gram-negative infections, and by 2002 they had become the most commonly prescribed class of antibiotics for adults in the United States. With widespread use, the class has become associated with a range of adverse events. Delafloxacin is a fluoroquinolone approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs). Delafloxacin is differentiated from other fluoroquinolones due to structural differences and in its activity against methicillin-resistant

methodsData from 2 completed phase III studies of delafloxacin for the treatment of ABSSSIs were pooled and are the primary focus of this paper. Additional support from the full safety analysis set (30 completed phase I to phase III clinical studies) is included where applicable.

resultsFewer patients in the pooled delafloxacin group had AESIs than in the comparator group (7.0% vs 9.2%, respectively). Delafloxacin had a low rate of discontinuations due to treatment-related adverse events (<1%). Serious adverse events occurred at similar rates in patients treated with delafloxacin vs comparators.

conclusionsSerious adverse events occurred at similar rates in patients treated with delafloxacin vs nonquinolone comparators used to treat ABSSSIs. CLINICALTRIALSGOV IDENTIFIER: NCT01984684 and NCT01811732.

Indexed as

adverse eventsdelafloxacinfluoroquinoloneMRSAsafety

Identifiers

PMID30349845
PMCPMC6189306
OpenAlexW2891340402

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.