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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in viral loads

Incidence of complicated hospital stay

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,286 Total Patients Enrolled

Roy F ChemalyPrincipal InvestigatorM.D. Anderson Cancer Center

Roy F Chemaly, MD,MPHPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Baloxavir Marboxil (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04712539 — Phase 2

Blood Cancers Research Study Groups: Arm I (oseltamivir, baloxavir marboxil), Arm II (oseltamivir)

Blood Cancers Clinical Trial 2023: Baloxavir Marboxil Highlights & Side Effects. Trial Name: NCT04712539 — Phase 2

Baloxavir Marboxil (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04712539 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that this research is looking to achieve?

"The primary focus of this study, which will be conducted over the course of a month, is to assess the incidence of complicated hospital stays. Outcomes that will be monitored include length of hospital stay, progression to lower respiratory tract infections, and changes in microbiome diversity. Data analysis will primarily involve comparisons between the interventional and control groups using Fischer's exact test or Wilcoxon rank sum test as appropriate. Additionally, alpha and beta diversity of the microbiome will be assessed using Agile Toolkit for Incisive Microbial Analyses with Shannon index being used to quantify alpha diversity."

Answered by AI

Does Baloxavir Marboxil have any harmful side effects?

"Baloxavir Marboxil has not been proven effective yet in clinical trials, however, there is some evidence to support its safety. Our team rates it as a 2."

Answered by AI

Baloxavir Marboxil is most commonly used to treat what?

"Baloxavir Marboxil is the recommended medication to break a fever. Additionally, it has been shown be effective in managing influenza during a pandemic outbreak as well as when caused by an influenza A virus."

Answered by AI

Is this research currently looking for new participants?

"That is correct, the information on clinicaltrials.gov verifies that this study is still recruiting patients. It was first posted on October 11th, 2021 and updated September 27th, 2022. They are looking for a total of 60 subjects at 1 location."

Answered by AI

Is this the first time Baloxavir Marboxil has been used in a research study?

"There are a total of 13 clinical trials being conducted for Baloxavir Marboxil at the moment. Of those, 4 have progressed to Phase 3 testing. Most of the trial locations are situated in New york, but there are 699 sites across America running tests."

Answered by AI

What is the desired number of participants for this research project?

"Yes, this clinical trial is still looking for patients. The listing on clinicaltrials.gov has not been updated recently, with the last update being on September 27th, 2022. They are hoping to find 60 participants total from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04712539.

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