Evidence map›Paper›PMID 31024969›Full record

ArticleOpen forum infectious diseases2019

Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza.

Grace Roberts, Shuguang Chen, Phillip Yates, Anuradha Madan, Jill Walker, Michael L Washburn, Andrew J Peat, Gary Soucie, Edward Kerwin, Sumita Roy-Ghanta

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 NCT02469298 (A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Oral Danirixin), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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.

NCT02469298 phase2completednot on this map

A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Oral Danirixin (GSK1325756) in the Treatment of Healthy Adults With Acute, Uncomplicated Influenza (201682)

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2016Enrolled45ConditionsVirus DiseasesArmsGSK1325756 (Danirixin), Placebo To Match GSK1325756, Oseltamivir Phosphate, Placebo To Match Oseltamivir Phosphate
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

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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

10 authors at 4 institutions in 2 countries.

Grace RobertsGlaxoSmithKline, Research Triangle Park, North Carolina.
Shuguang ChenGlaxoSmithKline, Upper Providence, Pennsylvania.
Phillip YatesGlaxoSmithKline, Stevenage, Herts, United Kingdom.
Anuradha MadanGlaxoSmithKline, Upper Providence, Pennsylvania.
Jill WalkerGlaxoSmithKline, Research Triangle Park, North Carolina.
Michael L WashburnGlaxoSmithKline, Upper Providence, Pennsylvania.
Andrew J PeatGlaxoSmithKline, Upper Providence, Pennsylvania.
Gary SoucieElite Clinical Trials, Blackfoot, Idaho.
Edward KerwinClinical Research Institute of Southern Oregon, Inc., Medford.
Sumita Roy-GhantaGlaxoSmithKline, Upper Providence, Pennsylvania.
GlaxoSmithKline (United States) · USClinical Research Institute · USGlaxoSmithKline (United Kingdom) · GBNorthwest Clinical Trials · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDanirixin (DNX), a selective and reversible CXC chemokine receptor 2 antagonist, inhibits neutrophil transmigration and activation. This study assessed the safety, tolerability, and clinical effect of DNX with and without oseltamivir (OSV) in adults with acute, uncomplicated influenza.

methodsThis was a placebo-controlled, double-blind, Phase IIa study. Participants (18-64 years) with influenza-like symptoms (onset ≤48 hours) and positive influenza rapid antigen test were randomized 2:1:2:1 to DNX, placebo, DNX+OSV, or OSV (75 mg each, administered twice daily for 5 days) and followed for 28 days. Primary endpoints included frequency of adverse events (AEs) and serious AEs (SAEs). The effect of DNX on virologic response and clinical effect on influenza symptoms were secondary endpoints.

resultsA total of 45 participants were enrolled, 35 of whom were confirmed influenza positive by polymerase chain reaction analysis. The highest incidence of AEs was in the placebo group (4 of 7, 57%), followed by the DNX+OSV (7 of 16, 44%), DNX (3 of 15, 20%), and OSV (0 of 7, 0%) groups. One SAE (T-wave abnormality) was reported in the DNX group (unrelated to treatment). No differences in viral load assessments were observed among treatment groups.

conclusionsDanirixin treatment was well tolerated and did not impede viral clearance.

Indexed as

CXC chemokine receptor 2 (CXCR2) antagonistdanirixin (DNX)influenzaoutpatientsafety

Identifiers

PMID31024969
PMCPMC6476494
OpenAlexW2939161161

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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.