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

Description

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Influenza

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Study Overview

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Study Details

Study overview

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.

Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts

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

Condition
Hematopoietic and Lymphoid Cell Neoplasm
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)\*\*
  • 1. Patient requires mechanical ventilation at time of enrollment
  • 2. Patient is younger than the age of 12 years old
  • 3. The patient is unable to tolerate oral therapy
  • 4. The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential).
  • 5. 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.
  • 6. The patient is unable to consent will be excluded

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Roy F Chemaly, MD,MPH, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2028-02-28