Actively Recruiting
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone.
CONDITIONS
Official Title
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hematopoietic cell transplant recipients or patients with hematological malignancy
- Diagnosed with influenza confirmed by a positive multiplex PCR test
- Evidence of lower respiratory tract infection or high-risk upper respiratory tract infection, defined by imaging, microbiological evidence, bronchoscopy, biopsy, or immunodeficiency scoring index of 3 or higher or severe neutropenia/lymphopenia
You will not qualify if you...
- Requires mechanical ventilation at enrollment
- Younger than 12 years old
- Unable to tolerate oral therapy
- Pregnant at screening (positive serum beta-HCG test for women of child-bearing potential)
- Taking prohibited medications including influenza antivirals except oseltamivir and baloxavir, or herbal therapies
- Unable to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Roy F. Chemaly, MD,MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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