InfluenzaNCT02334514
The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection
An observational study of Influenza, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- How many people
- 215 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults hospitalized and diagnosed with influenza
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.
Read the 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:
- 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.
- Conditions
- Influenza
- Keywords
- Influenza, Viral shedding, oseltamivir, Polymerase Chain Reaction
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with influenza | Patients diagnosed with influenza by PCR testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startNov 2014
- Primary completion30 May 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAL PAUL md, Rambam Health Care Campus
- Investigators
- Ami Neuberger, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334514
- Sponsor's protocol ID
- 0472-14-RMB paul CTIL
- Status last verified
- Sep 2017
- First submitted
- 1 Jan 2015
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02334514
- Acronym / sponsor ID
- 0472-14-RMB paul CTIL
- Conditions
- Influenza
- Keywords
- Influenza, Viral shedding, oseltamivir, Polymerase Chain Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with influenza | – | –Patients diagnosed with influenza by PCR testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults hospitalized and diagnosed with influenza
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ami Neuberger, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of viral shedding in patients who were hospitalized with influenza infection. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.