Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Study Overview
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Brief Summary
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Influenza outbreaks are a prevalent event in nursing homes (NHs). We will study baloxavir compared to oseltamivir when used for influenza prophylaxis when facilities identify an index incident case of influenza. This study will help guide nursing home's decision making and demonstrate the effectiveness of a novel antiviral for preventing influenza outbreaks.

Detailed Description
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A random study sample of about 1000 U.S. nursing homes (NHs), housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for the study. Participating facilities will be randomly allocated in a 1:1 ratio to oseltamivir or baloxavir for antiviral treatment and prophylaxis. Primary study data provided by facilities monthly during the influenza season will support primary and secondary endpoints along with administrative claims and public use datasets containing information on facility characteristics.

Official Title
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Comparative Effectiveness of Baloxavir Versus Oseltamivir for Influenza Outbreak Management in U.S. Nursing Homes

Conditions
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Influenza, Influenza, Human, Influenza -Like Illness

Intervention / Treatment
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* Drug: Oseltamivir
* Drug: Baloxavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older. Exclusion Criteria: Hospital-based facilities Facilities not submitting MDS data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic Cluster Randomized Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oseltamivir<br>Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza. | Drug: Oseltamivir<br>* Nursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza.<br>|
| Experimental: Baloxavir<br>Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza. | Drug: Baloxavir<br>* Nursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir | To demonstrate the non-inferiority of prophylactic baloxavir vs. oseltamivir to prevent influenza-like illness (ILI) after an index influenza case in nursing homes. | Up to 8 months each influenza season | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | To determine the difference in total outbreak duration for each outbreak occurring in nursing homes randomized to offer either single-dose baloxavir or oseltamivir for outbreak abatement during the 2021-2022 influenza season. | Up to 8 months each influenza season | 
| Facility-level data on antiviral courses of treatment administered from Medication Administration Records | To determine the difference in number of courses of treatment of baloxavir or oseltamivir needed for outbreak control in nursing homes randomized to baloxavir or oseltamivir. | Up to 8 months each influenza season | 
| Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims | To determine the difference in respiratory-related hospitalization rates during the 2021-2022 influenza season experienced by long-stay nursing home residents 65 and older living in nursing homes randomized to either baloxavir or oseltamivir. | Up to 8 months each influenza season | 
| Mortality from Medicare Vital Status File | To determine the differences in long-stay residents' mortality rates in nursing homes randomized to either baloxavir or oseltamivir. | Up to 8 months each influenza season | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outbreak, Antiviral Medication, Influenza, Nursing Home, Influenza Outbreak, Oseltamivir, Baloxavir