Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

NCT05012189 | Unknown Phase 4 FDA Drug

• 1 other identifier: INSI-202107
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Influenza, Human; Influenza -Like Illness

Keywords

Antiviral Medication; Influenza; Nursing Home; Influenza Outbreak; Outbreak; Oseltamivir; Baloxavir

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  Up to 8 months each influenza season

• Facility-level data on antiviral courses of treatment administered from Medication Administration Records

  Up to 8 months each influenza season

• Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims

  Up to 8 months each influenza season

• Mortality from Medicare Vital Status File

  Up to 8 months each influenza season

Study Arms (2)

Oseltamivir

ACTIVE COMPARATOR

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

Drug: Oseltamivir

Baloxavir

EXPERIMENTAL

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

Drug: Baloxavir

Interventions

Oseltamivir DRUG

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

Oseltamivir

Baloxavir DRUG

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

Baloxavir

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.

You may not qualify if:

• Hospital-based facilities
• Facilities not submitting MDS data

Sponsors & Collaborators

• Insight Therapeutics, LLC: lead
• Brown University: collaborator
• Case Western Reserve University: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Insight Therapeutics, LLC

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir; baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic Cluster Randomized Clinical Trial

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: August 6, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)