Influenza, HumanNCT03899571
Prophylactic Treatment With Oseltamivir
A study testing Oseltamivir Oral Capsule for 5 days post-exposure and Oseltamivir Oral Capsule for 10 days post-exposure in people with Influenza, Human, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Oseltamivir Oral Capsule for 5 days post-exposure and Oseltamivir Oral Capsule for 10 days post-exposure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteSlovenia
- Study dates
- 22 Jan 2019to 31 Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older
- exposure to influenza during hospitalization
- risk factors for influenza complications
- consent for participation obtained
Who cannot join
- younger than 18 years
- hematological malignancy
- hospitalized in intensive care unit
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial
The purpose of this study is to compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza.
- Conditions
- Influenza, Human
- Being tested
- Oseltamivir Oral Capsule for 5 days post-exposure, Oseltamivir Oral Capsule for 10 days post-exposure
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir Oral Capsule for 5 days post-exposureDrug
Patients will receive oseltamivir for 5 days after last influenza exposure.
Oseltamivir Oral Capsule for 10 days post-exposureDrug
Patients will receive oseltamivir for 10 days after last influenza exposure.
| Study group | Role | What they receive |
|---|---|---|
| 5 days | Active comparator | oral oseltamivir 75 mg once daily for 5 days post-exposure Receives: Drug: Oseltamivir Oral Capsule for 5 days post-exposure |
| 10 days | Active comparator | oral oseltamivir 75 mg once daily for 10 days post-exposure Receives: Drug: Oseltamivir Oral Capsule for 10 days post-exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy
Experiencing influenza like illness as self assessed by a patient and/or as assessed by a medical doctor while on prophylaxis with oseltamivir and during the following 10 days.
Measured: 10 days after oseltamivir prophylactic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start22 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daša Stupica, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899571
- Sponsor's protocol ID
- Tamiflu 2019
- Status last verified
- Nov 2020
- First submitted
- 31 Mar 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lepen L, Blagus R, Veluscek M, Saletinger R, Petrovec M, Bajrovic FF, Stupica D. Five-Day vs 10-Day Postexposure Chemoprophylaxis With Oseltamivir to Prevent Hospital Transmission of Influenza: A Noninferiority Randomized Open-Label Study. Open Forum Infect Dis. 2020 Jun 19;7(8):ofaa240. doi: 10.1093/ofid/ofaa240. eCollection 2020 Aug.
PubMed 32766383
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03899571
- Acronym / sponsor ID
- Tamiflu 2019
- Conditions
- Influenza, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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 compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 days | Active comparator | Drug: Oseltamivir Oral Capsule for 5 days post-exposureoral oseltamivir 75 mg once daily for 5 days post-exposure |
| 10 days | Active comparator | Drug: Oseltamivir Oral Capsule for 10 days post-exposureoral oseltamivir 75 mg once daily for 10 days post-exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- exposure to influenza during hospitalization
- risk factors for influenza complications
- consent for participation obtained
Key exclusion criteria (4 listed)
- younger than 18 years
- hematological malignancy
- hospitalized in intensive care unit
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oseltamivir Oral Capsule for 5 days post-exposurePatients will receive oseltamivir for 5 days after last influenza exposure. | Drug | 5 days |
| Oseltamivir Oral Capsule for 10 days post-exposurePatients will receive oseltamivir for 10 days after last influenza exposure. | Drug | 10 days |
Primary outcome
Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy
Time frame: 10 days after oseltamivir prophylactic therapy
Experiencing influenza like illness as self assessed by a patient and/or as assessed by a medical doctor while on prophylaxis with oseltamivir and during the following 10 days.
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 3 Nov 2020.
- Derived from this study: PubMed 32766383Lepen L, Blagus R, Veluscek M, Saletinger R, Petrovec M, Bajrovic FF, Stupica D. Five-Day vs 10-Day Postexposure Chemoprophylaxis With Oseltamivir to Prevent Hospital Transmission of Influenza: A Noninferiority Randomized Open-Label Study. Open Forum Infect Dis. 2020 Jun 19;7(8):ofaa240. doi: 10.1093/ofid/ofaa240. eCollection 2020 Aug.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oseltamivir Oral Capsule for 5 days post-exposure and Oseltamivir Oral Capsule for 10 days post-exposure in people with Influenza, Human, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 inclusion and 4 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 3 Nov 2020. 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 Slovenia. 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?
Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy (time frame: 10 days after oseltamivir prophylactic therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899571, which also lists 1 linked publication.
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 3 Nov 2020.