Baloxavir and Oseltamivir for Severe Flu in Immunocompromised Patients

This study is looking at how well baloxavir and oseltamivir work together to treat severe flu in people who have had a blood stem cell transplant or have a blood cancer. Baloxavir and oseltamivir are antiviral drugs that fight the flu virus. Researchers want to see if using both drugs helps more than oseltamivir alone by reducing the amount of flu virus in your body and preventing serious hospital stays. You might be able to join if you are 12 or older, have been diagnosed with the flu (confirmed by a specific test), and have a lower respiratory tract infection or a high-risk upper respiratory tract infection.

Study design
This interventional study plans to enroll 60 participants who will be randomly assigned to one of two groups: one receiving oseltamivir alone, and the other receiving oseltamivir with baloxavir.
What's involved
Participants will take medication by mouth for up to 10 days and have their viral loads measured on days 0, 1, 3, 7, 14, and 30.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 30 days to monitor for complicated hospital stays and changes in viral loads.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04712539

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

Recruiting
PHASE2Ages 12+Interventional
M.D. Anderson Cancer Center
~60 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Baloxavir MarboxilOseltamivir

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in viral loads
Measured over On day 0, 1, 3, 7, 14, and 30
+1 more outcome measured
Hematopoietic and Lymphoid Cell Neoplasm
Influenza
1 sites across 1 states
Texas1
  • Roy F Chemaly, MD,MPH · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Changes in viral loadsOn day 0, 1, 3, 7, 14, and 30

    Will be measured via repeat nasopharyngeal swabs at each follow up on day 0, 1, 3, 7, 14 and 30 for influenza quantification.

  • Incidence of complicated hospital stayUp to 30 days

    Defined as a hospital admission that was either prolonged (greater than 7 days), requiring intensive care unit level of care or death at day 30 as a result of influenza infection.