Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Sponsor

Insight Therapeutics, LLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT05012189

Collaborator

Brown University (Other), Case Western Reserve University (Other), Genentech, Inc. (Industry)

1,000

Enrollment

Location

Arms

27.8

Anticipated Duration (Months)

35.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Influenza, Human Influenza -Like Illness	Drug: Oseltamivir Drug: Baloxavir	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pragmatic Cluster Randomized Clinical TrialPragmatic Cluster Randomized Clinical Trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 6, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Oseltamivir

Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza.

Drug: Oseltamivir

Nursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza.

Experimental: Baloxavir

Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza.

Drug: Baloxavir

Nursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.
Facilities with at least 80% of their long-stay population 65 years of age or older