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
About this trial
This is an interventional prevention trial for Influenza, Human
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
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
NCT ID
NCT03899571
First Posted
March 31, 2019
Last Updated
November 2, 2020
Sponsor
University Medical Centre Ljubljana
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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