Prophylactic Treatment With Oseltamivir

NCT ID: NCT03899571

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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5 days

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

Group Type ACTIVE_COMPARATOR

Oseltamivir Oral Capsule for 5 days post-exposure

Intervention Type DRUG

Patients will receive oseltamivir for 5 days after last influenza exposure.

10 days

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

Group Type ACTIVE_COMPARATOR

Oseltamivir Oral Capsule for 10 days post-exposure

Intervention Type DRUG

Patients will receive oseltamivir for 10 days after last influenza exposure.

Interventions

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Oseltamivir Oral Capsule for 5 days post-exposure

Patients will receive oseltamivir for 5 days after last influenza exposure.

Intervention Type DRUG

Oseltamivir Oral Capsule for 10 days post-exposure

Patients will receive oseltamivir for 10 days after last influenza exposure.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Daša Stupica

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type DERIVED
PMID: 32766383 (View on PubMed)

Other Identifiers

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Tamiflu 2019

Identifier Type: -

Identifier Source: org_study_id