Clinical trial NCT02334514: The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Influenza
Viral shedding
oseltamivir
Polymerase Chain Reaction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults hospitalized and diagnosed with influenza

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of viral shedding in patients who were hospitalized with influenza infection.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ami Neuberger, MD
role: PRINCIPAL_INVESTIGATOR
References: