Post-exposure Influenza Prophylaxis in a Hospital Setting | NCT07496736

Studies
Post-exposure Influenza Prophylaxis in a Hospital Setting

NCT07496736

Sponsor

University Medical Centre Ljubljana

Status

Active, not recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Influenza

Interventions

Oseltamivir
Oseltamivir

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

Mar 31, 2028Estimated

First Submitted Date

Mar 22, 2026

First Submission Date that Met QC Criteria

Mar 22, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2026

Last Update Posted Date

Apr 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daša Stupica, MD, PhD, assoc prof, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oseltamivir 5 days	Active Comparator	post-exposure influenza prophylaxis with oseltamivir for 5 days	Drug: Oseltamivir
oseltamivir 10 days	Active Comparator	post-exposure influenza prophylaxis with oseltamivir for 10 days	Drug: Oseltamivir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oseltamivir	Drug	oseltamivir 5 days	oseltamivir 5 days
Oseltamivir

Measure	Description	Time Frame
frequency of influenza		10 days after completing prophylaxis

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana		Ljubljana		1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

As expected from May 01, 2026 to May 31 2028

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053139	Oseltamivir

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D053138	Cyclohexenes
D003510

Browse Leaves

Not provided

Browse Branches

Not provided