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Completed

NCT Number: NCT02334514

The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection

The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Health Care Campus

Haifa, Israel

About this study

A prospective cohort study will be undertaken during the influenza season of 2015 in Rambam Medical Center, Haifa, Israel.

The study group will include inpatients older than 18 years, who have clinical presentation suggestive of influenza virus infection defined by the World Health Organization and the Center for Disease Control and Prevention, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose, who were found positive to influenza virus by polymerase chain reaction test, and in whom anti viral treatment was indicated.

Exclusion criteria

  • Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs.
  • Pregnant women.
  • Patients who were treated with oseltamivir in the previous 6 months.

Patients who approve their participation will to fill a questionnaire, and a polymerase chain reaction assay for influenza will be performed as follows:

The first sample will be taken right before the first dose of oseltamavir, and then on days 2, 3 and 5.

Samples will be stored at a temperature of +4 Celsius degrees for a maximum of 48 hours.

Outcomes: we will consider a positive polymerase chain reaction test 3 days after the initiation of treatment as prolonged shedding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose,
  • positive to influenza virus by PCR test
  • anti viral treatment was indicated

Exclusion criteria

  • Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs.
  • Pregnant women.
  • Patients who were treated with oseltamivir in the previous 6 months

Treatment and study plan

Primary outcomes

  1. Duration of viral shedding in patients who were hospitalized with influenza infection.

    Time frame: 1 week

    PCR for influenza virus will be taken before the initiation of treatment, and at days 2, 3 and 5. Prolonged viral shedding will be defined as PCR positive at day 3.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection Among Adults - a Prospective, Cohort Study.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2015
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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