Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2).

The Pediatric Infectious Disease Journal
Jeffrey BakerPedro A Piedra

Abstract

Baloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor that has previously demonstrated efficacy in the treatment of influenza in adults and adolescents. We assessed the safety and efficacy of baloxavir in otherwise healthy children with acute influenza. MiniSTONE-2 (Clinicaltrials.gov: NCT03629184) was a double-blind, randomized, active controlled trial enrolling children 1-<12 years old with a clinical diagnosis of influenza. Children were randomized 2:1 to receive either a single dose of oral baloxavir or oral oseltamivir twice daily for 5 days. The primary endpoint was incidence, severity and timing of adverse events (AEs); efficacy was a secondary endpoint. In total, 173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group. Characteristics of participants were similar between treatment groups. Overall, 122 AEs were reported in 84 (48.6%) children. Incidence of AEs was similar between baloxavir and oseltamivir groups (46.1% vs. 53.4%, respectively). The most common AEs were gastrointestinal (vomiting/diarrhea) in both groups [baloxavir: 12 children (10.4%); oseltamivir: 10 children (17.2%)]. No deaths, serious AEs or hospitalizations were reported. Median ti...Continue Reading

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Citations

Nov 8, 2020·Antiviral Research·Hassan ZaraketNelson Lee
Feb 12, 2021·Clinical Microbiology Reviews·Edward C HolmesPedro A Piedra
Apr 28, 2021·Pediatric Transplantation·Annabelle de St MauriceNatasha Halasa
May 29, 2021·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Takuhiro SonoyamaTakeki Uehara
May 23, 2021·Journal of Microbiology, Immunology, and Infection = Wei Mian Yu Gan Ran Za Zhi·Yu-Chi KuoCheng-Yi Wang
Jul 14, 2021·Journal of Microbiology, Immunology, and Infection = Wei Mian Yu Gan Ran Za Zhi·Chih-Cheng LaiPo-Ren Hsueh
Jul 11, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Frederick G HaydenArnold S Monto
Aug 21, 2021·Mayo Clinic Proceedings. Innovations, Quality & Outcomes·Warren A JonesRuth Carrico
Sep 9, 2021·Pediatrics·UNKNOWN COMMITTEE ON INFECTIOUS DISEASES
Dec 18, 2021·Seminars in Respiratory and Critical Care Medicine·Liam S O'Driscoll, Ignacio Martin-Loeches
Dec 18, 2021·Seminars in Respiratory and Critical Care Medicine·Emanuele PalombaAndrea Gori
Jan 1, 2022·Intensive Care Medicine Experimental·C H MastersonJ G Laffey

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Methods Mentioned

BETA
genotyping

Clinical Trials Mentioned

NCT03629184
NCT03684044

Software Mentioned

MiniSTONE
SAS

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