Clinical trial

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

Name

INSI-202107

Description

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.

Trial arms

Trial start

2021-08-06

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Oseltamivir

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

Arms:

Oseltamivir

Baloxavir

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

Arms:

Baloxavir

Size

1000

Primary endpoint

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

Up to 8 months each influenza season

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic Cluster Randomized Clinical Trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}

Updated at

2023-03-15

1 organization

2 products

3 indications

Organization

Product

Indication

Indication

Indication

Influenza-like Illness

Product

Baloxavir