Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts
M.D. Anderson Cancer Center
60 participants
Oct 11, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Hematopoeitic cell transplant recipients OR hematological malignancy patients
- Diagnosed with influenza ⱡ
- Evidence of LRTI* or high risk upper respiratory tract infection (URTI)**
- ⱡ A positive multiplex PCR for influenza is required to confirm a diagnosis of influenza infection.
- * LRTI will be defined as influenza cases that have evidence of disease below the level of the trachea on either imaging only (possible LRTI), imaging and microbiological evidence of lower airway disease with a bronchoscopy (probable LRTD) or pathological evidence of disease via biopsy (proven LRTI).
- ** High risk URI will be defined as those cases of influenza that do not have microbiological nor radiological evidence of LRTI, yet they have an immunodeficiency scoring index (ISI) of 3 or greater as defined by Shah D et al (19) for HCT recipients or severe neutropenia (ANC ≤500 cells/ml) and/or lymphopenia (ALC ≤200 cells/ml) for HM patients.
Exclusion Criteria6
- Patient requires mechanical ventilation at time of enrollment
- Patient is younger than the age of 12 years old
- The patient is unable to tolerate oral therapy
- The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential).
- The patient is on a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine) and herbal therapies.
- The patient is unable to consent will be excluded
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Interventions
Given PO
Given PO
Locations(1)
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NCT04712539