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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04712539
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Influenza

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baloxavir Marboxil — DRUG
    Given PO
  • Oseltamivir — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Oct 11, 2021
Status verified
Jan 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Arm I (oseltamivir, baloxavir marboxil)
    Patients receive oseltamivir PO BID for up to 10 days and baloxavir marboxil PO every 72 hours for a total of 3 doses in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (oseltamivir)
    Patients receive oseltamivir PO BID for up to 10 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Changes in viral loads [ Time Frame: On day 0, 1, 3, 7, 14, and 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Roy F. Chemaly, MD,MPH
[email protected]
713-792-6830
Roy F. Chemaly, MD,MPH (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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