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Prophylactic Treatment With Oseltamivir

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Oseltamivir Oral Capsule for 5 days post-exposure
Oseltamivir Oral Capsule for 10 days post-exposure
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical center Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5 days

10 days

Arm Description

oral oseltamivir 75 mg once daily for 5 days post-exposure

oral oseltamivir 75 mg once daily for 10 days post-exposure

Outcomes

Primary Outcome Measures

Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy
Experiencing influenza like illness as self assessed by a patient and/or as assessed by a medical doctor while on prophylaxis with oseltamivir and during the following 10 days.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2019
Last Updated
November 2, 2020
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT03899571
Brief Title
Prophylactic Treatment With Oseltamivir
Official Title
Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 days
Arm Type
Active Comparator
Arm Description
oral oseltamivir 75 mg once daily for 5 days post-exposure
Arm Title
10 days
Arm Type
Active Comparator
Arm Description
oral oseltamivir 75 mg once daily for 10 days post-exposure
Intervention Type
Drug
Intervention Name(s)
Oseltamivir Oral Capsule for 5 days post-exposure
Intervention Description
Patients will receive oseltamivir for 5 days after last influenza exposure.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir Oral Capsule for 10 days post-exposure
Intervention Description
Patients will receive oseltamivir for 10 days after last influenza exposure.
Primary Outcome Measure Information:
Title
Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy
Description
Experiencing influenza like illness as self assessed by a patient and/or as assessed by a medical doctor while on prophylaxis with oseltamivir and during the following 10 days.
Time Frame
10 days after oseltamivir prophylactic therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Medical center Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32766383
Citation
Lepen L, Blagus R, Veluscek M, Saletinger R, Petrovec M, Bajrovic FF, Stupica D. Five-Day vs 10-Day Postexposure Chemoprophylaxis With Oseltamivir to Prevent Hospital Transmission of Influenza: A Noninferiority Randomized Open-Label Study. Open Forum Infect Dis. 2020 Jun 19;7(8):ofaa240. doi: 10.1093/ofid/ofaa240. eCollection 2020 Aug.
Results Reference
derived

Learn more about this trial

Prophylactic Treatment With Oseltamivir

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