Clinical trial NCT05012189: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza
Influenza, Human
Influenza -Like Illness
Keywords: Antiviral Medication
Influenza
Nursing Home
Influenza Outbreak
Outbreak
Oseltamivir
Baloxavir
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Brown University
name: Case Western Reserve University
name: Genentech, Inc.
First posted: 2021-08-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic Cluster Randomized Clinical Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir
timeFrame: Up to 8 months each influenza season
Secondary outcomes:
measure: 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
timeFrame: Up to 8 months each influenza season
measure: Facility-level data on antiviral courses of treatment administered from Medication Administration Records
timeFrame: Up to 8 months each influenza season
measure: Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims
timeFrame: Up to 8 months each influenza season
measure: Mortality from Medicare Vital Status File
timeFrame: Up to 8 months each influenza season
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Insight Therapeutics, LLC
state: Virginia
Study officials:
References: