PMID- 31024969
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231011
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 6
IP  - 4
DP  - 2019 Apr
TI  - Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, 
      and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza.
PG  - ofz072
LID - 10.1093/ofid/ofz072 [doi]
LID - ofz072
AB  - BACKGROUND: Danirixin (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. METHODS: This 
      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. RESULTS: A 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. 
      CONCLUSIONS: Danirixin treatment was well tolerated and did not impede viral 
      clearance.
FAU - Roberts, Grace
AU  - Roberts G
AD  - GlaxoSmithKline, Research Triangle Park, North Carolina.
FAU - Chen, Shuguang
AU  - Chen S
AD  - GlaxoSmithKline, Upper Providence, Pennsylvania.
FAU - Yates, Phillip
AU  - Yates P
AD  - GlaxoSmithKline, Stevenage, Herts, United Kingdom.
FAU - Madan, Anuradha
AU  - Madan A
AD  - GlaxoSmithKline, Upper Providence, Pennsylvania.
FAU - Walker, Jill
AU  - Walker J
AD  - GlaxoSmithKline, Research Triangle Park, North Carolina.
FAU - Washburn, Michael L
AU  - Washburn ML
AD  - GlaxoSmithKline, Upper Providence, Pennsylvania.
FAU - Peat, Andrew J
AU  - Peat AJ
AD  - GlaxoSmithKline, Upper Providence, Pennsylvania.
FAU - Soucie, Gary
AU  - Soucie G
AD  - Elite Clinical Trials, Blackfoot, Idaho.
FAU - Kerwin, Edward
AU  - Kerwin E
AD  - Clinical Research Institute of Southern Oregon, Inc., Medford.
FAU - Roy-Ghanta, Sumita
AU  - Roy-Ghanta S
AD  - GlaxoSmithKline, Upper Providence, Pennsylvania.
LA  - eng
PT  - Journal Article
DEP - 20190422
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC6476494
OTO - NOTNLM
OT  - CXC chemokine receptor 2 (CXCR2) antagonist
OT  - danirixin (DNX)
OT  - influenza
OT  - outpatient
OT  - safety
EDAT- 2019/04/27 06:00
MHDA- 2019/04/27 06:01
PMCR- 2019/04/22
CRDT- 2019/04/27 06:00
PHST- 2018/11/19 00:00 [received]
PHST- 2019/03/01 00:00 [accepted]
PHST- 2019/04/27 06:00 [entrez]
PHST- 2019/04/27 06:00 [pubmed]
PHST- 2019/04/27 06:01 [medline]
PHST- 2019/04/22 00:00 [pmc-release]
AID - ofz072 [pii]
AID - 10.1093/ofid/ofz072 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2019 Apr 22;6(4):ofz072. doi: 10.1093/ofid/ofz072. 
      eCollection 2019 Apr.