Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks
- Conditions
- Influenza, HumanInfluenzaInfluenza -Like Illness
- Interventions
- Registration Number
- NCT05012189
- Lead Sponsor
- Insight Therapeutics, LLC
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.
- Hospital-based facilities
- Facilities not submitting MDS data
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oseltamivir Oseltamivir Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza. Baloxavir Baloxavir Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza.
- Primary Outcome Measures
Name Time Method Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir Up to 8 months each influenza season To demonstrate the non-inferiority of prophylactic baloxavir vs. oseltamivir to prevent influenza-like illness (ILI) after an index influenza case in nursing homes.
- Secondary Outcome Measures
Name Time Method Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims Up to 8 months each influenza season 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.
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 Up to 8 months each influenza season 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.
Facility-level data on antiviral courses of treatment administered from Medication Administration Records Up to 8 months each influenza season 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.
Mortality from Medicare Vital Status File Up to 8 months each influenza season To determine the differences in long-stay residents' mortality rates in nursing homes randomized to either baloxavir or oseltamivir.
Trial Locations
- Locations (1)
Insight Therapeutics, LLC
🇺🇸Norfolk, Virginia, United States