Evidence map›Paper›PMID 31041358›Full record

ArticleOpen forum infectious diseases2019

Efficacy and Safety of Danirixin (GSK1325756) Co-administered With Standard-of-Care Antiviral (Oseltamivir): A Phase 2b, Global, Randomized Study of Adults Hospitalized With Influenza.

Anuradha Madan, Shuguang Chen, Phillip Yates, Michael L Washburn, Grace Roberts, Andrew J Peat, Yu Tao, Michael F Parry, Otis Barnum, Micah T McClain and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02927431 (A Phase II, Global, Randomized Study to Evaluate the Efficacy and Safety of Danirixin), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT02927431 phase2terminatednot on this map

A Phase II, Global, Randomized Study to Evaluate the Efficacy and Safety of Danirixin (GSK1325756) Co-administered With a Standard-of-care Antiviral (Oseltamivir), in the Treatment of Adults Hospitalized With Influenza

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2017Enrolled10ConditionsVirus DiseasesArmsDanirixin 15 mg FBE, Danirixin 50 mg FBE, Placebo, Oseltamivir 75 mg
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. A narrative review of chemokine receptors CXCR1 and CXCR2 and their role in acute respiratory distress syndrome.European respiratory review : an official journal of the European Respiratory Society · 2024
    Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Antiviral Approaches against Influenza Virus.Clinical microbiology reviews · 2023
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. 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

11 authors at 6 institutions in 2 countries.

Anuradha MadanGlaxoSmithKline, Upper Providence, Pennsylvania.
Shuguang ChenGlaxoSmithKline, Upper Providence, Pennsylvania.
Phillip YatesGlaxoSmithKline, Stevenage, United Kingdom.
Michael L WashburnGlaxoSmithKline, Upper Providence, Pennsylvania.
Grace RobertsGlaxoSmithKline, Research Triangle Park, North Carolina.
Andrew J PeatGlaxoSmithKline, Upper Providence, Pennsylvania.
Yu TaoGlaxoSmithKline, Upper Providence, Pennsylvania.
Michael F ParryStamford Hospital, Stamford, Connecticut.
Otis BarnumNatchitoches Regional Medical Center, Natchitoches, Louisiana.
Micah T McClainDuke University Center for Applied Genomics and Precision Medicine, Durham, North Carolina.
Sumita Roy-GhantaGlaxoSmithKline, Upper Providence, Pennsylvania.
GlaxoSmithKline (United States) · USDuke University · USGlaxoSmithKline (United Kingdom) · GBRegional Medical Center · USResearch Triangle Park Foundation · USStamford Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExcessive neutrophil migration has been correlated with influenza symptom severity. Danirixin (GSK1325756), a selective and reversible antagonist of C-X-C chemokine receptor 2, decreases neutrophil activation and transmigration to areas of inflammation. This study evaluated the efficacy and safety of intravenous (IV) danirixin co-administered with oseltamivir for the treatment of adults hospitalized with influenza.

methodsIn this phase 2b, double-blind, 3-arm study (NCT02927431), influenza-positive participants were randomized 2:2:1 to receive danirixin 15mg intravenously (IV) twice daily (bid) + oral oseltamivir 75mg bid (OSV), danirixin 50mg IV bid + OSV, or placebo IV bid + OSV, for up to 5 days. The primary endpoint was time to clinical response (TTCR).

resultsIn total, 10 participants received study treatment (danirixin 15mg + OSV, n = 4; danirixin 50mg + OSV, n = 4; placebo + OSV, n = 2) before the study was terminated early due to low enrollment. All participants achieved a clinical response. Median (95% confidence interval) TTCR was 4.53 days (2.95, 5.71) for danirixin 15mg + OSV, 4.76 days (2.71, 5.25) for danirixin 50mg + OSV, and 1.33 days (0.71, 1.95) for placebo + OSV. Adverse events (AEs) were generally of mild or moderate intensity; no serious AEs were considered treatment-related. Interleukin-8 levels increased in nasal samples (using synthetic absorptive matrix strips) and decreased serum neutrophil-elastase-mediated degradation of elastin decreased in danirixin-treated participants, suggesting effective target engagement.

conclusionsInterpretation of efficacy results is restricted by the low participant numbers. The safety and tolerability profile of danirixin was consistent with previous studies. CLINICAL TRIAL INFORMATION: The registration data for the trial are in the ClinicalTrials.gov database, number NCT02927431, and in the EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/) as GSK study 201023, EudraCT 2016-002512-40. Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com.

Indexed as

CXCR2 antagonistdanirixinhospitalizationinfluenzaneutrophils

Identifiers

PMID31041358
PMCPMC6483311
OpenAlexW2935553567

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.