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Antiviral

Baloxavir + Oseltamivir for Severe Flu

Phase 2

Recruiting

Led By Roy F Chemaly

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with influenza

Hematopoeitic cell transplant recipients OR hematological malignancy patients

Must not have

The patient is unable to consent will be excluded

Patient is younger than the age of 12 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on day 0, 1, 3, 7, 14, and 30

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs to treat severe influenza in people who have had a stem cell transplant or have a blood cancer.

Who is the study for?

This trial is for adults with severe flu who've had a blood stem cell transplant or have blood cancer. They must show signs of lower respiratory tract infection (LRTI) or be at high risk due to weakened immunity. Participants need confirmed influenza and can't be on certain antiviral drugs, unable to take oral meds, pregnant, under 12 years old, unable to consent, or require mechanical breathing support.

What is being tested?

The study tests if combining two antiviral drugs—Baloxavir and Oseltamivir—is more effective in treating severe flu in immunocompromised patients than using Oseltamivir alone. Baloxavir reduces viral growth while Oseltamivir blocks virus spread from infected cells.

What are the potential side effects?

Possible side effects include digestive issues like nausea and diarrhea, headaches, bronchitis symptoms such as coughing and wheezing, sinus inflammation causing stuffy nose or sore throat; rare but serious reactions may involve changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with the flu.

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I have had a bone marrow transplant or have blood cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to give my consent for treatment.

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I am under 12 years old.

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I cannot take medicine by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on day 0, 1, 3, 7, 14, and 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on day 0, 1, 3, 7, 14, and 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 0, 1, 3, 7, 14, and 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in viral loads

Incidence of complicated hospital stay

Secondary study objectives

30-day mortality

Changes in microbiome diversity

Length of hospital stay

+4 more

Side effects data

From 2020 Phase 4 trial • 481 Patients • NCT04141930

Diarrhea

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Study Drug Eligible

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (oseltamivir, baloxavir marboxil)Experimental Treatment2 Interventions

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.

Group II: Arm II (oseltamivir)Active Control1 Intervention

Patients receive oseltamivir PO BID for up to 10 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baloxavir marboxil

FDA approved

Oseltamivir

FDA approved

0 / 5Eligibility criteria met