Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Summary

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

Timeline

Start

2019-10-10

Primary completion

2024-05-10

Completion

2024-05-10

Publications

• Monto AS, Kuhlbusch K, Bernasconi C, Cao B, Cohen HA, Graham E, Hurt AC, Katugampola L, Kamezawa T, Lauring AS, McLean B, Takazono T, Widmer A, Wildum S, Cowling BJ. Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza. N Engl J Med. 2025 Apr 24;392(16):1582-1593. doi: 10.1056/NEJMoa2413156.
• Komeda T, Takazono T, Hosogaya N, Ogura E, Fujiwara M, Miyauchi H, Ajisawa Y, Iwata S, Watanabe H, Honda K, Kitanishi Y, Hara K, Mukae H. Comparison of Household Transmission of Influenza Virus From Index Patients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study. Clin Infect Dis. 2021 Jun 1;72(11):e859-e867. doi: 10.1093/cid/ciaa1622.

Drugs

Indications