NCT07496736
Active, not recruiting
Phase 3
Post-Exposure Influenza Chemoprophylaxis With Oseltamivir for Five Days vs Ten Days in Acute-Care Hospital: a Non-Inferiority Randomized Open-Label Study
University Medical Centre Ljubljana1 site in 1 country200 target enrollmentStarted: December 1, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- frequency of influenza
Overview
Brief Summary
The purpose of this study is to compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza in a hospital setting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •exposure to influenza during hospitalization
- •risk factors for influenza complications
- •consent for participation obtained
Exclusion Criteria
- •younger than 18 years
- •hematological malignancy
- •hospitalized in intensive care unit
- •refusal to participate
Arms & Interventions
oseltamivir 10 days
Active Comparator
post-exposure influenza prophylaxis with oseltamivir for 10 days
Intervention: Oseltamivir (Drug)
oseltamivir 5 days
Active Comparator
post-exposure influenza prophylaxis with oseltamivir for 5 days
Intervention: Oseltamivir (Drug)
Outcomes
Primary Outcomes
frequency of influenza
Time Frame: 10 days after completing prophylaxis
Secondary Outcomes
No secondary outcomes reported
Investigators
Daša Stupica
MD, PhD, assoc prof
University Medical Centre Ljubljana
Study Sites (1)
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