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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
Nursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza.
Nursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza.
Insight Therapeutics, LLC
Norfolk, Virginia, United States
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.
Time frame: Up to 8 months each influenza season
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Up to 8 months each influenza season