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Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Primary Purpose

Influenza, Influenza, Human, Influenza -Like Illness

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Oseltamivir

Baloxavir

About this trial

This is an interventional prevention trial for Influenza focused on measuring Antiviral Medication, Influenza, Nursing Home, Influenza Outbreak, Outbreak, Oseltamivir, Baloxavir

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

Hospital-based facilities
Facilities not submitting MDS data

Sites / Locations

Insight Therapeutics, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oseltamivir

Baloxavir

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

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

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

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

To determine the differences in long-stay residents' mortality rates in nursing homes randomized to either baloxavir or oseltamivir.

Full Information

NCT ID

NCT05012189

First Posted

August 12, 2021

Last Updated

March 14, 2023

Sponsor

Insight Therapeutics, LLC

Collaborators

Brown University, Case Western Reserve University, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05012189

Brief Title

Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 6, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insight Therapeutics, LLC

Collaborators

Brown University, Case Western Reserve University, Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Influenza, Human, Influenza -Like Illness

Keywords

Antiviral Medication, Influenza, Nursing Home, Influenza Outbreak, Outbreak, Oseltamivir, Baloxavir

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Pragmatic Cluster Randomized Clinical Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oseltamivir

Arm Type

Active Comparator

Arm Description

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

Arm Title

Baloxavir

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Oseltamivir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Baloxavir

Intervention Description

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

Primary Outcome Measure Information:

Title

Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir

Description

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