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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334514
• Other study ID #: 0472-14-RMB paul CTIL
• Status: Completed
• Phase: N/A
• First received: January 1, 2015
• Last updated: September 27, 2017
• Start date: November 2014
• Est. completion date: July 30, 2017

Study information

• Verified date: September 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: July 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of viral shedding in patients who were hospitalized with influenza infection.	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.	1 week