Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

NCT ID: NCT05012189

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Influenza Influenza, Human Influenza -Like Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic Cluster Randomized Clinical Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oseltamivir

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

Group Type ACTIVE_COMPARATOR

Oseltamivir

Intervention Type DRUG

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

Baloxavir

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

Group Type EXPERIMENTAL

Baloxavir

Intervention Type DRUG

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

Interventions

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Oseltamivir

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

Intervention Type DRUG

Baloxavir

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Insight Therapeutics, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Insight Therapeutics, LLC

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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INSI-202107

Identifier Type: -

Identifier Source: org_study_id

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