NCT04712539RecruitingPhase 2
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 · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Jan 2021
- Start date
- Oct 2021
- Primary completion date
- Feb 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT04712539
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From Oct 2021 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient is unable to tolerate oral therapy
- 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.
Lab values
- The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential).
Age
- Patient is younger than the age of 12 years old
Other
- Patient requires mechanical ventilation at time of enrollment
- The patient is unable to consent will be excluded
Who the study is looking for
- Hematopoeitic cell transplant recipients OR hematological malignancy patients
- Diagnosed with influenza ⱡ
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.