Status:
RECRUITING
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Influenza
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 tr...
Detailed 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 fro...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 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 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
Exclusion
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04712539
Start Date
October 11 2021
End Date
February 28 2028
Last Update
August 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030