Post-exposure Influenza Prophylaxis in a Hospital Setting

April 26, 2026 updated by: Daša Stupica, University Medical Centre Ljubljana

Post-Exposure Influenza Chemoprophylaxis With Oseltamivir for Five Days vs Ten Days in Acute-Care Hospital: a Non-Inferiority Randomized Open-Label Study

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oseltamivir 5 days
post-exposure influenza prophylaxis with oseltamivir for 5 days
Drug: Oseltamivir
oseltamivir 5 days
Drug: Oseltamivir
oseltamivir 10 days
Active Comparator: oseltamivir 10 days
post-exposure influenza prophylaxis with oseltamivir for 10 days
Drug: Oseltamivir
oseltamivir 5 days
Drug: Oseltamivir
oseltamivir 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of influenza
Time Frame: 10 days after completing prophylaxis
10 days after completing prophylaxis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tamiflu 2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The anonymous data generated or analysed during the trial will be available from the corresponding author upon reasonable request.

IPD Sharing Time Frame

As expected from May 01, 2026 to May 31 2028

IPD Sharing Access Criteria

The anonymous data generated or analysed during the trial will be available from the corresponding author upon reasonable request after the study results are published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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