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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Baloxavir Marboxil
DrugGiven PO
Oseltamivir
DrugGiven PO
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Arm I (oseltamivir, baloxavir marboxil)Experimental treatment 2 interventions
Group B: Arm II (oseltamivir)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in viral loads
Will be measured via repeat nasopharyngeal swabs at each follow up on day 0, 1, 3, 7, 14 and 30 for influenza quantification.
Time frame
On day 0, 1, 3, 7, 14, and 302
Incidence of complicated hospital stay
Defined as a hospital admission that was either prolonged (greater than 7 days), requiring intensive care unit level of care or death at day 30 as a result of influenza infection.
Time frame
Up to 30 daysSecondary outcomes
1
Rate of resistance to antiviral agents
Will compare variables between the interventional and control groups using Fischer's exact test or Wilcoxon rank sum test when appropriate.
Time frame
Up to 30 days2
Progression to lower respiratory tract infections
Will compare variables between the interventional and control groups using Fischer's exact test or Wilcoxon rank sum test when appropriate.
Time frame
Up to 30 days3
Length of hospital stay
Will compare variables between the interventional and control groups using Fischer's exact test or Wilcoxon rank sum test when appropriate.
Time frame
Up to 30 days4
Oxygen requirement
Will compare variables between the interventional and control groups using Fischer's exact test or Wilcoxon rank sum test when appropriate.
Time frame
Up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov