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Led by M.D. Anderson Cancer Center · Updated on 2026-07-16
60
Participants Needed
1
Research Sites
N/A
Total Duration
This phase II trial evaluates the combination of baloxavir marboxil with oseltamivir compared to oseltamivir alone for treating severe influenza infections in patients who have undergone hematopoietic stem cell transplants or have hematological malignancies. The study focuses on measuring changes in influenza viral loads and clinical outcomes such as complicated hospital stays to better understand treatment effects in this immunocompromised population. Participants are randomly assigned to one of two groups one group receives oseltamivir twice daily for up to 10 days along with baloxavir marboxil every 72 hours for three doses, while the other group receives oseltamivir twice daily alone for up to 10 days. Treatment continues unless the disease progresses or unacceptable toxicity occurs. After treatment, patients are followed for 30 days to assess outcomes. Throughout the study, participants undergo viral load testing at multiple time points days 0, 1, 3, 7, 14, and 30 along with monitoring for antiviral resistance, respiratory complications, oxygen needs, length of hospital stay, mortality, and changes in upper airway microbiome. Safety and clinical outcomes are carefully measured to evaluate the effects of the combination therapy over the 30-day follow-up period.
CONDITIONS
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
R
Roy F. Chemaly, MD,MPH
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M.D. Anderson Cancer Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Baloxavir + Oseltamivir | Oseltamivir alone |
|---|---|---|
| What it is | Oral combination of baloxavir marboxil plus oseltamivir given together as the investigational regimen | Oral oseltamivir given alone as the active comparator regimen |
| Role in trial | Investigational arm testing addition of baloxavir to standard oseltamivir therapy | Active comparator arm using oseltamivir alone |
| Primary use | Treatment of severe influenza infection in immunocompromised patients | Treatment of severe influenza infection in immunocompromised patients |
| How it is given | Oseltamivir twice daily orally and baloxavir every 72 hours for up to three doses | Oseltamivir twice daily orally for up to ten days |
| Evidence status | Evidence remains preliminary from this Phase II trial investigating efficacy and safety | Oseltamivir is established as standard therapy for severe influenza in high‑risk patients |
| Important risks | Safety of prolonged combination therapy is uncertain; initial case reports suggest tolerability but further data needed | Adverse effects are generally well characterized in standard use |
| Important limitations | Small trial size; no published outcomes yet; generalizability limited | Monotherapy may not adequately prevent resistance or protracted viral shedding in immunocompromised hosts |
| Patient impact | Direct patient‑relevant outcome impact not yet established | Established benefit in reducing influenza complications when given promptly in high‑risk patients |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 days
Participants receive either oseltamivir alone or oseltamivir combined with baloxavir marboxil by mouth according to their assigned group. Treatment lasts up to 10 days unless the disease progresses or side effects occur.
Duration - 30 days
Participants are followed for 30 days after treatment to monitor viral load changes, clinical outcomes, and any complications.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Pauline Vetter, Ana Rita Goncalves Cabecinhas, Manuel Schibler...
https://pubmed.ncbi.nlm.nih.gov/41891860/M.D. Anderson Cancer Center
Lead Sponsor
