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NCT05012189 Clinical Trial

Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Influenza Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05012189
Other study ID # INSI-202107
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date August 6, 2021
Est. completion date December 2023

Study information
Verified date March 2023
Source Insight Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oseltamivir
Nursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza.
• Baloxavir
Nursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza.

Locations
Country Name City State
United States Insight Therapeutics, LLC Norfolk Virginia

Sponsors (4)
Lead Sponsor Collaborator
Insight Therapeutics, LLC Brown University, Case Western Reserve University, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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