Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza; Influenza, Human; Influenza -Like Illness
• Intervention / Treatment: Drug: Oseltamivir; Drug: Baloxavir

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Insight Therapeutics, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Insight Therapeutics, LLC
• Collaborators: Brown University; Genentech, Inc.; Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Influenza; Outbreak; Nursing Home; Oseltamivir; Baloxavir; Antiviral Medication; Influenza Outbreak
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir; Baloxavir
• Other Study ID Numbers: INSI-202107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No