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Prophylactic Treatment With Oseltamivir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03899571
Recruitment Status : Active, not recruiting
First Posted : April 2, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Influenza, Human Drug: Oseltamivir Oral Capsule for 5 days post-exposure Drug: Oseltamivir Oral Capsule for 10 days post-exposure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

Arm Intervention/treatment
Active Comparator: 5 days
oral oseltamivir 75 mg once daily for 5 days post-exposure
Drug: Oseltamivir Oral Capsule for 5 days post-exposure
Patients will receive oseltamivir for 5 days after last influenza exposure.

Active Comparator: 10 days
oral oseltamivir 75 mg once daily for 10 days post-exposure
Drug: Oseltamivir Oral Capsule for 10 days post-exposure
Patients will receive oseltamivir for 10 days after last influenza exposure.




Primary Outcome Measures :
  1. Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899571


Locations
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Slovenia
University Medical center Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
University Medical Centre Ljubljana

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Responsible Party: Daša Stupica, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03899571     History of Changes
Other Study ID Numbers: Tamiflu 2019
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action