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Antiviral
Baloxavir and Oseltamivir for Influenza
Phase 4
Waitlist Available
Research Sponsored by Insight Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months each influenza season
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare the effectiveness of two different drugs in preventing influenza outbreaks in nursing homes.
Eligible Conditions
- Pneumonia
- Flu
- Influenza
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months each influenza season
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months each influenza season
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir
Secondary study objectives
Facility-level data on antiviral courses of treatment administered from Medication Administration Records
Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims
Mortality from Medicare Vital Status File
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BaloxavirExperimental Treatment1 Intervention
Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza.
Group II: OseltamivirActive Control1 Intervention
Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza.
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Who is running the clinical trial?
Insight Therapeutics, LLCLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a long-stay resident of a NH in the United States.
Research Study Groups:
This trial has the following groups:- Group 1: Oseltamivir
- Group 2: Baloxavir
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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