Clinical trial · Interventional
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Influenza | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baloxavir Marboxil | Drug | — | UNRESOLVED |
| Oseltamivir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (oseltamivir, baloxavir marboxil)
- description
- Patients receive oseltamivir PO BID for up to 10 days and baloxavir marboxil PO every 72 hours for a total of 3 doses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Baloxavir Marboxil
- Drug: Oseltamivir
- type
- ACTIVE_COMPARATOR
- label
- Arm II (oseltamivir)
- description
- Patients receive oseltamivir PO BID for up to 10 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Oseltamivir
Primary outcomes (2)
- measure
- Changes in viral loads
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVetter P, Cabecinhas ARG, Schibler M, Kaiser L, Cruz-Fauquex K, Chalandon Y, Masouridi-Levrat S, Neofytos D. Use of baloxavir as adjunctive antiviral therapy to neuraminidase inhibitors in severely immunocompromised individuals infected with influenza. Antimicrob Agents Chemother. 2026 May 6;70(5):e0165925. doi: 10.1128/aac.01659-25. Epub 2026 Mar 27. PMID 41891860