Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

Summary

This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone.

Timeline

Start

2021-10-11

Primary completion

2028-02-28

Completion

2028-02-28

Publications

• Vetter P, Cabecinhas ARG, Schibler M, Kaiser L, Cruz-Fauquex K, Chalandon Y, Masouridi-Levrat S, Neofytos D. Use of baloxavir as adjunctive antiviral therapy to neuraminidase inhibitors in severely immunocompromised individuals infected with influenza. Antimicrob Agents Chemother. 2026 May 6;70(5):e0165925. doi: 10.1128/aac.01659-25. Epub 2026 Mar 27.

Drugs

Indications