Combining baloxavir and oseltamivir to treat severe influenza in immunocompromised patients

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

This study is testing if combining two antiviral medications, baloxavir and oseltamivir, can help people with severe influenza who have weakened immune systems due to cancer treatments feel better compared to just using oseltamivir alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT04712539 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients who have received a hematopoietic cell transplant or have a hematological malignancy and are diagnosed with influenza.

Not a fit: Patients without a history of hematopoietic cell transplant or hematological malignancy, or those not diagnosed with influenza, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve recovery outcomes for immunocompromised patients suffering from severe influenza.

How similar studies have performed: While combining antiviral therapies is a common approach, this specific combination for this patient population is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Houston, Texas

• 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

Conditions Hematopoietic and Lymphoid Cell Neoplasm; Influenza