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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02334514
Enrollment
215
Registered
2015-01-08
Start date
2014-11-30
Completion date
2017-07-30
Last updated
2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Viral shedding, oseltamivir, Polymerase Chain Reaction

Brief summary

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

Detailed description

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: 1. 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. 2. Pregnant women. 3. 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.

Interventions

None listed

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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, 2. positive to influenza virus by PCR test 3. anti viral treatment was indicated

Exclusion criteria

1. 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. 2. Pregnant women. 3. Patients who were treated with oseltamivir in the previous 6 months

Design outcomes

Primary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026