InfluenzaPhase 4NCT05012189
Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks
A Phase 4 study testing Oseltamivir and Baloxavir in people with Influenza and Influenza, Human, run by Insight Therapeutics, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza, Human, Influenza -Like Illness
- What is being tested?
- Oseltamivir and Baloxavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.
Who cannot join
- Hospital-based facilities
- Facilities not submitting MDS data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Baloxavir Versus Oseltamivir for Influenza Outbreak Management in U.S. Nursing Homes
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.
Read the 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.
- Conditions
- Influenza, Influenza, Human, Influenza -Like Illness
- Being tested
- Oseltamivir, Baloxavir
- Keywords
- Antiviral Medication, Influenza, Nursing Home, Influenza Outbreak, Outbreak, Oseltamivir, Baloxavir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Nursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza.
BaloxavirDrug
Nursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir | Active comparator | Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza. Receives: Drug: Oseltamivir |
| Baloxavir | Experimental | Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza. Receives: Drug: Baloxavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Up to 8 months each influenza season
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.
Measured: Up to 8 months each influenza season
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.
Measured: Up to 8 months each influenza season
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.
Measured: Up to 8 months each influenza season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start6 Aug 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic Cluster Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insight Therapeutics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Case Western Reserve University, Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012189
- Sponsor's protocol ID
- INSI-202107
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Baloxavir Versus Oseltamivir for Influenza Outbreak Management in U.S. Nursing Homes
- ClinicalTrials.gov ID
- NCT05012189
- Acronym / sponsor ID
- INSI-202107
- Conditions
- Influenza, Influenza, Human, Influenza -Like Illness
- Keywords
- Antiviral Medication, Influenza, Nursing Home, Influenza Outbreak, Outbreak, Oseltamivir, Baloxavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Insight Therapeutics, LLCUniversity, hospital or other
- Collaborators
- Brown University, Case Western Reserve University, Genentech, Inc.
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Cluster Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir | Active comparator | Drug: OseltamivirNursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza. |
| Baloxavir | Experimental | Drug: BaloxavirNursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.
Key exclusion criteria (2 listed)
- Hospital-based facilities
- Facilities not submitting MDS data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OseltamivirNursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza. | Drug | Oseltamivir |
| BaloxavirNursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza. | Drug | Baloxavir |
Primary outcome
Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir
Time frame: Up to 8 months each influenza season
To demonstrate the non-inferiority of prophylactic baloxavir vs. oseltamivir to prevent influenza-like illness (ILI) after an index influenza case in nursing homes.
4 secondary outcomes
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
Time frame: Up to 8 months each influenza season
Facility-level data on antiviral courses of treatment administered from Medication Administration Records
Time frame: Up to 8 months each influenza season
Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims
Time frame: Up to 8 months each influenza season
Mortality from Medicare Vital Status File
Time frame: Up to 8 months each influenza season
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oseltamivir and Baloxavir in people with Influenza and Influenza, Human, run by Insight Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir (time frame: Up to 8 months each influenza season). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.