Baloxavir for Influenza, Human

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Insight Therapeutics, LLC, Norfolk, VA
Influenza, Human+2 More
Baloxavir - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new antiviral drug can prevent influenza outbreaks in nursing homes.

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Eligible Conditions

  • Influenza, Human
  • Flu caused by Influenza
  • influenza-like illness or flu-like symptoms

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Baloxavir will improve 1 primary outcome and 4 secondary outcomes in patients with Influenza, Human. Measurement will happen over the course of Up to 8 months each influenza season.

Month 8
Facility-level data on antiviral courses of treatment administered from Medication Administration Records
Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims
Mortality from Medicare Vital Status File
Outbreak duration defined as the time of the first laboratory-confirmed case of influenza to 7 days following the last identified case of influenza-like illness requiring treatment with baloxavir or oseltamivir
Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Oseltamivir
1 of 2
Baloxavir
1 of 2
Active Control
Experimental Treatment

This trial requires 1000 total participants across 2 different treatment groups

This trial involves 2 different treatments. Baloxavir is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Baloxavir
Drug
Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza.
Oseltamivir
Drug
Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 months each influenza season
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 8 months each influenza season for reporting.

Closest Location

Insight Therapeutics, LLC - Norfolk, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.
Facilities with at least 80% of their long-stay population 65 years of age or older

Patient Q&A Section

What are the signs of influenza, human?

"Flu can cause headache, body aches, and vomiting. Symptoms can range from the mild to severe. Symptoms can include weakness, muscle aches, and feeling tired. Symptoms of [influenza](https://www.withpower.com/clinical-trials/influenza) can appear from 2 to 14 days after exposure.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for influenza, human?

"Specific therapies vary widely for influenza. Most cases are resolved with supportive treatment. However, many people remain hospitalized with respiratory distress for some or all of their time in hospital." - Anonymous Online Contributor

Unverified Answer

Can influenza, human be cured?

"While the 1918 flu did not cure the infected, these results are promising. In a retrospective study of 64 pediatric patients from the 1940s, the cumulative survival was 77.5% ± 9.4%, at a median of 13.7 months. More studies are needed." - Anonymous Online Contributor

Unverified Answer

How many people get influenza, human a year in the United States?

"In the United States, seasonal [influenza](https://www.withpower.com/clinical-trials/influenza) is common (about 8 million cases annually) during the autumn and winter. In the United States, the 1918 flu killed a total of 50 million people, and 40 million more cases occurred. Although influenza can be an especially dangerous pandemic disease, with a global mortality of about one million, the 1918 influenza pandemic was relatively mild in the United States due to the lack of the highly lethal seasonal flu. However, because a similar virus will reappear in 20 to 35 years, a reoccurrence of the mild 1918 influenza may be possible. Further, the 1918 influenza may have been partially prevented by the introduction of vaccines such as the first-ever influenza vaccine." - Anonymous Online Contributor

Unverified Answer

What is influenza, human?

"Influenza is an infectious disease of the respiratory tract that has a significant impact on human health. In 1918, influenza caused the deaths of up to 20 million people worldwide and was responsible for the deaths of half a million children. Influenza is an infectious virus that can contaminate food and water causing severe outbreaks. Influenza is the predominant form of infection among people in a healthy population. The severity of infections is enhanced by the human immunodeficiency virus (HIV). However, the risk of influenza in people with HIV is not yet fully understood. It is well established that in healthy people, influenza can cause a transient decrease in white blood cell and platelet counts." - Anonymous Online Contributor

Unverified Answer

What causes influenza, human?

"Influenza is a highly contagious infection with a broad host range. Its global spread relies on human movements of large numbers of human travelers and the close contact with animals. Influenza viruses circulate year-round in an animal-adapted form. Humans seem to be the main reservoir for influenza, but an occasional reassortment between subtypes allows the virus to evolve into a broader host range. This allows influenza to adapt to a wider host range, as seen in recent influenza pandemics. Genetic exchange of viruses between animals and humans contributes to influenza evolution and evolution of new forms. Finally, human-animal contact can facilitate viral infection via the transfer of zoonotic pathogens." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of baloxavir?

"The most commonly observed AEs were rash, headache, and itch that were present in >90% of those administered baloxavir, and fatigue, headache, musculoskeletal pain, and back pain were also reported." - Anonymous Online Contributor

Unverified Answer

What is the latest research for influenza, human?

"It is important to check your vaccination status before heading out to see if you will need to get inoculations for human [influenza](https://www.withpower.com/clinical-trials/influenza) during the flu season. The influenza vaccine protects against both seasonal and pandemic strains. Please find the latest reports of influenza vaccines at [Center for Disease Control (CDC)\n(https://www.cdc.gov/influev/flu/home.htm)-and-[Health Agency of Canada (CAHA) (http://www.cahaconline.ca/)\n-flu.htm.] and [Health Canada (HCSPS) (http://www.hcsps.gc.ca/flu.d-pdf)] to obtain the latest recommendations." - Anonymous Online Contributor

Unverified Answer

How does baloxavir work?

"Baloxavir is a prodrug, which is metabolized by the liver enzyme CYP3A and excreted via the faeces to active baloxavir. It has been shown that the [blood plasma concentration of baloxavir]] increases proportionally to the [blood plasma concentration of CYP3A] in drug abusers. The CYP3A has to become a more important excipient in drug users, because they do not make a new one. The CYP3A will metabolize any new drugs to give in the body the desired concentration. In case of baloxavir a new generation will come and give an additional effect." - Anonymous Online Contributor

Unverified Answer

Is baloxavir typically used in combination with any other treatments?

"Baloxavir is used in clinical practice in conjunction with other antiretroviral therapies. The majority of patients studied also received other antiviral agents, including oseltamivir, lopinavir, or amantadine. Baloxavir typically resulted in higher rates of virologic suppression and a higher probability of treatment completion. Patients studied in clinical practice were in a range of categories with varying treatment experience or complexity." - Anonymous Online Contributor

Unverified Answer

What is baloxavir?

"Baloxavir has both antiviral and immune modulating activities which may increase both its efficacy and its safety. It may be a useful treatment option for adults and children infected with H1N1 influenza in the event of an outbreak in North America.Baloxavir may be used for children without a clear diagnosis of influenza. However, the risks of it should be weighed against its benefits. A randomized clinical trial (RCT) in adults should be done; as such, treatment guidelines for children infected are still unknown." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets influenza, human?

"[The following values apply nationally (except for states of Idaho and Vermont; for these states actual mean age is indicated in brackets)]\n"Source: Centers for Disease Control & Prevention"\n1) 1st outbreak: 49 (54.1)\n2) 2nd outbreak: 44\n3) 3rd outbreak: 49·6 (54.4)\n4) 4th outbreak: 46\n5) 5th outbreak: 50\n6) 6th outbreak: 47\n7) 7th outbreak: 48\nThe average age of individuals infected with swine influenza is 48 years old." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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