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Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

NCT04712539 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-11

No results posted yet for this study

Summary

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

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Influenza

Interventions

DRUG

Baloxavir Marboxil

Given PO

DRUG

Oseltamivir

Given PO

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Roy F Chemaly, MD,MPH · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2028-02-28
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712539 on ClinicalTrials.gov