Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorM.D. Anderson Cancer Center
About this trial
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 criteria
Qualifiers
Hematopoeitic cell transplant recipients OR hematological malignancy patients
Diagnosed with influenza ⱡ
Evidence of LRTI* or high risk upper respiratory tract infection (URTI)**
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Baloxavir Marboxil
- Oseltamivir
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov