Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts
M.D. Anderson Cancer Center
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.
Description
PRIMARY OBJECTIVE: I. To compare the efficacy of baloxavir marboxil (baloxavir) in combination with oseltamivir to oseltamivir monotherapy as measured by changes in influenza viral loads at day 1 from baseline for treatment of severe influenza infections in immunocompromised hosts (such as hematopoietic cell transplant \[HCT\] recipients and hematological malignancy \[HM\] patients) and compare the main clinical outcome, complicated hospital stay between the intervention arm and control arm. SECONDARY OBJECTIVES: I. To compare the efficacy of baloxavir in combination with oseltamivir to ose…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Hematopoeitic cell transplant recipients OR hematological malignancy patients 2. Diagnosed with influenza ⱡ 3. 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 biops…
Interventions
- DrugBaloxavir Marboxil
Given PO
- DrugOseltamivir
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas