Baloxavir + Oseltamivir for Severe Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of two antiviral drugs, baloxavir (Xofluza) and oseltamivir (Tamiflu), used together to treat severe flu infections. The goal is to determine if combining these drugs reduces the severity or shortens the duration of the flu compared to oseltamivir alone. The trial seeks participants who have undergone a blood stem cell transplant or have blood-related cancers and are currently experiencing a severe flu infection. Participants should have confirmed flu and either a serious lower or high-risk upper respiratory infection. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You may need to stop taking certain medications. The trial does not allow the use of other influenza antiviral drugs besides oseltamivir and baloxavir, and herbal therapies are also prohibited.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that baloxavir is generally safe and easy to tolerate. Studies have found that baloxavir causes fewer stomach issues, such as nausea and vomiting, compared to oseltamivir. It also appears to reduce fever more quickly. One study found that baloxavir works well in children, suggesting it is safe for many age groups.
Oseltamivir is a common flu treatment with well-established safety. When combined with baloxavir, the treatment might offer additional benefits without significant added risk. No major safety concerns have been reported when these drugs are used together.12345Why do researchers think this study treatment might be promising?
Researchers are excited about combining baloxavir marboxil and oseltamivir for severe flu because this duo might offer a one-two punch against the virus. While oseltamivir is already a standard treatment that helps stop the flu virus from spreading in your body, adding baloxavir marboxil could enhance the effect by preventing the virus from replicating in the first place. This combination could potentially shorten the duration of symptoms and reduce complications more effectively than oseltamivir alone. With flu seasons becoming increasingly unpredictable, having a more powerful treatment option could make a significant difference in patient outcomes.
What evidence suggests that this trial's treatments could be effective for severe flu?
Research has shown that baloxavir marboxil reduces the flu virus in the body more quickly than oseltamivir. This trial will compare two treatment approaches: one group will receive a combination of baloxavir marboxil and oseltamivir, while another group will receive oseltamivir alone. Baloxavir marboxil, when combined with oseltamivir, may enhance treatment effectiveness for severe flu, particularly in individuals with weakened immune systems. Additionally, baloxavir is associated with fewer side effects than oseltamivir alone, making it a promising option for treating severe flu.13678
Who Is on the Research Team?
Roy F. Chemaly, MD,MPH
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with severe flu who've had a blood stem cell transplant or have blood cancer. They must show signs of lower respiratory tract infection (LRTI) or be at high risk due to weakened immunity. Participants need confirmed influenza and can't be on certain antiviral drugs, unable to take oral meds, pregnant, under 12 years old, unable to consent, or require mechanical breathing support.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oseltamivir orally twice daily for up to 10 days and baloxavir marboxil every 72 hours for a total of 3 doses
Follow-up
Participants are monitored for changes in influenza viral loads and other health outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Baloxavir Marboxil
- Oseltamivir
Baloxavir Marboxil is already approved in United States, Japan, European Union for the following indications:
- Acute uncomplicated influenza within 2 days of illness onset in people aged ≥5 years who are otherwise healthy, or in people aged ≥12 years who are at high risk of developing influenza-related complications
- Influenza A and B virus infections
- Treatment of uncomplicated influenza in adults and adolescents aged 12 years and older weighing at least 40 kg
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor