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NCT03899571 Clinical Trial

Prophylactic Treatment With Oseltamivir

Influenza, Human Clinical Trial

Official title:
Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03899571
Other study ID # Tamiflu 2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2019
Est. completion date March 31, 2020

Study information
Verified date November 2020
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oseltamivir Oral Capsule for 5 days post-exposure
Patients will receive oseltamivir for 5 days after last influenza exposure.
• Oseltamivir Oral Capsule for 10 days post-exposure
Patients will receive oseltamivir for 10 days after last influenza exposure.

Locations
Country Name City State
Slovenia University Medical center Ljubljana Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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