Influenza Clinical Trial
Official title:
Comparative Effectiveness of Baloxavir Versus Oseltamivir for Influenza Outbreak Management in U.S. Nursing Homes
Verified date | March 2023 |
Source | Insight Therapeutics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Insight Therapeutics, LLC | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Insight Therapeutics, LLC | Brown University, Case Western Reserve University, Genentech, Inc. |
United States,
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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