Prophylactic Treatment With Oseltamivir
Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial
1 other identifier
interventional
222
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2019
CompletedFirst Submitted
Initial submission to the registry
March 31, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedNovember 3, 2020
November 1, 2020
1.2 years
March 31, 2019
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
10 days after oseltamivir prophylactic therapy
Study Arms (2)
5 days
ACTIVE COMPARATORoral oseltamivir 75 mg once daily for 5 days post-exposure
10 days
ACTIVE COMPARATORoral oseltamivir 75 mg once daily for 10 days post-exposure
Interventions
Patients will receive oseltamivir for 5 days after last influenza exposure.
Patients will receive oseltamivir for 10 days after last influenza exposure.
Eligibility Criteria
You may qualify if:
- years or older
- exposure to influenza during hospitalization
- risk factors for influenza complications
- consent for participation obtained
You may not qualify if:
- younger than 18 years
- hematological malignancy
- hospitalized in intensive care unit
- refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical center Ljubljana
Ljubljana, Slovenia
Related Publications (1)
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.
PMID: 32766383DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 31, 2019
First Posted
April 2, 2019
Study Start
January 22, 2019
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
November 3, 2020
Record last verified: 2020-11