Efficacy of Combination Baloxavir and Oseltamivir Therapy in Influenza-Infected Immunocompromised Patients

What this Trial Is About

Researchers are evaluating the combination of baloxavir marboxil and oseltamivir versus oseltamivir alone for treating severe influenza infections in patients who have had a blood stem cell transplant or have blood-related cancers. This phase II trial aims to assess how well the combination reduces influenza viral loads and improves clinical outcomes like complicated hospital stays in these immunocompromised patients. Participants are randomly assigned to one of two groups: one group receives oral oseltamivir twice daily for up to 10 days plus baloxavir marboxil every 72 hours for up to three doses, while the other group receives only oral oseltamivir twice daily for up to 10 days. Treatment continues unless the disease worsens or side effects become unacceptable. After treatment, patients are followed for 30 days to monitor outcomes. During the study, researchers will collect data on viral load changes at multiple time points, incidence of resistance to antiviral drugs, development of lower respiratory infections, oxygen needs, respiratory failure, changes in the upper airway microbiome, hospital stay length, and mortality within 30 days. Safety and effectiveness are closely monitored throughout the treatment and follow-up periods.

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