Combining baloxavir and oseltamivir to treat severe influenza in immunocompromised patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of baloxavir marboxil in combination with oseltamivir for treating severe influenza infections in patients who have undergone hematopoietic stem cell transplants or have hematological malignancies. The study aims to compare the viral load changes in patients receiving the combination therapy versus those receiving oseltamivir alone. Patients will be randomized into two groups, with one group receiving both antiviral medications and the other receiving only oseltamivir. The trial will also assess the incidence of antiviral resistance and other clinical outcomes over a 30-day follow-up period.

Why it matters

Who can join: the full rules

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 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:

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Roy F Chemaly, MD,MPH — M.D. Anderson Cancer Center
• Study coordinator: Roy F. Chemaly, MD,MPH
• Email: rfchemaly@mdanderson.org
• Phone: 713-792-6830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.