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

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Baloxavir; Oseltamivir

Criteria

Inclusion Criteria:

• Hematopoietic cell transplant recipients OR hematological malignancy patients

• Diagnosed with influenza

• A positive multiplex polymerase chain reaction (PCR) for influenza is required to confirm a diagnosis of influenza infection

• Evidence of LRTI or high risk upper respiratory tract infection (URTI)

• 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 (absolute neutrophil count [ANC] =< 500 cells/ml) and/or lymphopenia (absolute blood lymphocyte count [ALC] =< 200 cells/ml) for HM patients.

Exclusion Criteria:

• 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

• 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