InfluenzaNCT04297462
Different Regimens in Influenza Postexposure Chemoprophylaxis in Children
A study testing Oseltamivir 3 days and Oseltamivir 7 days in people with Influenza and Exposure, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
Although the vaccination is the preferred method of influenza prevention, there are some occasions on which a postexposure prophylaxis (PEP) is required. Two neuraminidase inhibitors (NAIs) may be used in chemoprophylaxis in children: oral oseltamivir, and inhaled zanamivir. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Exposure, Prevention
- What is being tested?
- Oseltamivir 3 days and Oseltamivir 7 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 17 Nov 2016to 31 Dec 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients hospitalized at the Pediatric Ward
- age: 0-18 years old
- confirmed contact with a person diagnosed with influenza
- patient's, patient's parent/tutor's informed consent
Who cannot join
- lack of an informed consent
- more than 48 hours after the first contact with influenza
- severe adverse reaction to the drug- discontinuation of the prophylaxis
- important to a parent/tutor drug intolerance (e.g. lack of tolerance of a drug's taste)
- new contact with influenza after chemoprophylaxis has finished
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
The Centre of Postgraduate Medical Education
Warsaw, Masovian Voivodeship, 01-813
August E. Wrotek, MD PhD, (+48)228641167, august.wrotek@bielanski.med.pl
About this study
Official title: Efficacy of Different Regimens in Influenza Postexposure Chemoprophylaxis With Oral Neuraminidase Inhibitor in Children
Although the vaccination is the preferred method of influenza prevention, there are some occasions on which a postexposure prophylaxis (PEP) is required. Two neuraminidase inhibitors (NAIs) may be used in chemoprophylaxis in children: oral oseltamivir, and inhaled zanamivir. Both, oseltamivir and zanamivir, are effective in treatment and in prophylaxis of influenza, and the efficacy is calculated to reach 70-90%. Oseltamivir is used more frequently, since zanamivir is licensed in older children (5 years of age and above), and children under the age of 5 years are at higher risk of influenza complications. Oseltamivir use correlated in children with higher risk of vomiting, with no increased risk of other adverse events, including those observed in adult patients (nausea, renal events, and psychiatric effects). The PEP may be indicated by individual patient's characteristics (e.g. patients in high-risk group) or epidemiological reasons, i.e. prevention of institutional outbreaks.The one research that analyzed efficacy of 3-days PEP versus 7 or 10-days and showed overall efficacy of shorter oseltamivir prophylaxis to be high and comparable to that of longer regimens. The study included several pediatric patients and made the investigators perform such an analysis in pediatric population. In this randomized controlled trial, the investigators aimed to compare efficacy, safety, and costs of 3 versus 7-days prophylaxis with oral oseltamivir in children hospitalized. The hypothesis is that 3-days duration of PEP is not less effective than 7-days PEP, and patients might gain from lower number of adverse reactions related to drug administration.
Read the detailed description
Only applies to patients hospitalized due to other than influenza reasons. If a proven contact with influenza has taken place (influenza diagnosed by signs/symptoms and positive rapid influenza diagnostic test and/or PCR), a patient may be enrolled.
- Conditions
- Influenza, Exposure, Prevention
- Being tested
- Oseltamivir 3 days, Oseltamivir 7 days
- Keywords
- influenza, chemoprevention, oseltamivir, child, infant
- 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 3 daysDrug
Also called 3-days postexposure chemoprophylaxis with oseltamivir
Non-inferiority study of 3 versus 7-days duration of PEP
Oseltamivir 7 daysDrug
Also called 7-days postexposure chemoprophylaxis with oseltamivir
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| 3-days postexposure chemoprophylaxis | Experimental | Oseltamivir given orally, 3mg per each body kg, once a day during three consecutive days after the contact with influenza Receives: Drug: Oseltamivir 3 days |
| 7-days postexposure chemoprophylaxis | Active comparator | Oseltamivir given orally, 3mg per each body kg, once a day during seven consecutive days after the contact with influenza Receives: Drug: Oseltamivir 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postexposure chemoprophylaxis efficacy
Percent of patients who did not have influenza in each study arm.
Measured: up to 7 days after PEP has finished
Oseltamivir safety
Presence of the following adverse reactions to drug (in percents): nausea, vomiting, skin hypersensitivity (including rash), sleep disorders, consciousness disorders, convulsions, fever related to drug administration, symptomatic arrhythmias, behavioral changes
Measured: up to 7 days after PEP has finished
Postexposure chemoprophylaxis costs
Cost of drugs used in each arm, costs of treatment of adverse reactions
Measured: up to 7 days after PEP has finished
Secondary outcomes (4)
Need for hospitalization in case of influenza after failed chemoprophylaxis
A need for hospitalization if influenza is present within 7 days after PEP completion
Measured: Up to 28 days
Duration of influenza signs and symptoms after failed chemoprophylaxis
Length of period when signs and symptoms are present
Measured: Up to 28 days
Presence of complications in case of influenza after failed chemoprophylaxis
Presence of influenza complications: pneumonia, bronchitis, otitis media, need for antibiotic treatment, neurological sequelae, ICU transfer, death
Measured: Up to 28 days
Fever in case of influenza after failed chemoprophylaxis
Highest fever and duration of fever
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start17 Nov 2016
- Primary completion31 Mar 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomly allocated into 3 or 7-days postexposure chemoprophylaxis group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, August Wrotek, Centre of Postgraduate Medical Education
- Investigators
- August E. Wrotek, MD PhD, Principal investigator, The Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297462
- Sponsor's protocol ID
- 77/PB/2016
- Status last verified
- Sep 2020
- First submitted
- 18 Feb 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ishiguro N, Oyamada R, Nasuhara Y, Yamada T, Miyamoto T, Imai S, Akizawa K, Fukumoto T, Iwasaki S, Iijima H, Ono K. Three-day regimen of oseltamivir for postexposure prophylaxis of influenza in wards. J Hosp Infect. 2016 Oct;94(2):150-3. doi: 10.1016/j.jhin.2016.05.012. Epub 2016 May 25.
PubMed 27346624Wrotek A, Jackowska T. A noninferiority randomized open-label pilot study of 3- versus 7-day influenza postexposure prophylaxis with oseltamivir in hospitalized children. Sci Rep. 2024 Jun 20;14(1):14192. doi: 10.1038/s41598-024-65244-5.
PubMed 38902383
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Regimens in Influenza Postexposure Chemoprophylaxis With Oral Neuraminidase Inhibitor in Children
- ClinicalTrials.gov ID
- NCT04297462
- Acronym / sponsor ID
- 77/PB/2016
- Conditions
- Influenza, Exposure, Prevention
- Keywords
- influenza, chemoprevention, oseltamivir, child, infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Mar 2020 (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.
Although the vaccination is the preferred method of influenza prevention, there are some occasions on which a postexposure prophylaxis (PEP) is required. Two neuraminidase inhibitors (NAIs) may be used in chemoprophylaxis in children: oral oseltamivir, and inhaled zanamivir. Both, oseltamivir and zanamivir, are effective in treatment and in prophylaxis of influenza, and the efficacy is calculated to reach 70-90%. Oseltamivir is used more frequently, since zanamivir is licensed in older children (5 years of age and above), and children under the age of 5 years are at higher risk of influenza complications. Oseltamivir use correlated in children with higher risk of vomiting, with no increased risk of other adverse events, including those observed in adult patients (nausea, renal events, and psychiatric effects). The PEP may be indicated by individual patient's characteristics (e.g. patients in high-risk group) or epidemiological reasons, i.e. prevention of institutional outbreaks.The one research that analyzed efficacy of 3-days PEP versus 7 or 10-days and showed overall efficacy of shorter oseltamivir prophylaxis to be high and comparable to that of longer regimens. The study included several pediatric patients and made the investigators perform such an analysis in pediatric population. In this randomized controlled trial, the investigators aimed to compare efficacy, safety, and costs of 3 versus 7-days prophylaxis with oral oseltamivir in children hospitalized. The hypothesis is that 3-days duration of PEP is not less effective than 7-days PEP, and patients might gain from lower number of adverse reactions related to drug administration.
Detailed description
Only applies to patients hospitalized due to other than influenza reasons. If a proven contact with influenza has taken place (influenza diagnosed by signs/symptoms and positive rapid influenza diagnostic test and/or PCR), a patient may be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomly allocated into 3 or 7-days postexposure chemoprophylaxis group
| Arm | Type | Receives |
|---|---|---|
| 3-days postexposure chemoprophylaxis | Experimental | Drug: Oseltamivir 3 daysOseltamivir given orally, 3mg per each body kg, once a day during three consecutive days after the contact with influenza |
| 7-days postexposure chemoprophylaxis | Active comparator | Drug: Oseltamivir 7 daysOseltamivir given orally, 3mg per each body kg, once a day during seven consecutive days after the contact with influenza |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patients hospitalized at the Pediatric Ward
- age: 0-18 years old
- confirmed contact with a person diagnosed with influenza
- patient's, patient's parent/tutor's informed consent
Key exclusion criteria (5 listed)
- lack of an informed consent
- more than 48 hours after the first contact with influenza
- severe adverse reaction to the drug- discontinuation of the prophylaxis
- important to a parent/tutor drug intolerance (e.g. lack of tolerance of a drug's taste)
- new contact with influenza after chemoprophylaxis has finished
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 3 daysAlso: 3-days postexposure chemoprophylaxis with oseltamivirNon-inferiority study of 3 versus 7-days duration of PEP | Drug | 3-days postexposure chemoprophylaxis |
| Oseltamivir 7 daysAlso: 7-days postexposure chemoprophylaxis with oseltamivirActive comparator | Drug | 7-days postexposure chemoprophylaxis |
Primary outcome
Postexposure chemoprophylaxis efficacy
Time frame: up to 7 days after PEP has finished
Percent of patients who did not have influenza in each study arm.
Oseltamivir safety
Time frame: up to 7 days after PEP has finished
Presence of the following adverse reactions to drug (in percents): nausea, vomiting, skin hypersensitivity (including rash), sleep disorders, consciousness disorders, convulsions, fever related to drug administration, symptomatic arrhythmias, behavioral changes
Postexposure chemoprophylaxis costs
Time frame: up to 7 days after PEP has finished
Cost of drugs used in each arm, costs of treatment of adverse reactions
4 secondary outcomes
Need for hospitalization in case of influenza after failed chemoprophylaxis
Time frame: Up to 28 days
Duration of influenza signs and symptoms after failed chemoprophylaxis
Time frame: Up to 28 days
Presence of complications in case of influenza after failed chemoprophylaxis
Time frame: Up to 28 days
Fever in case of influenza after failed chemoprophylaxis
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 27346624Ishiguro N, Oyamada R, Nasuhara Y, Yamada T, Miyamoto T, Imai S, Akizawa K, Fukumoto T, Iwasaki S, Iijima H, Ono K. Three-day regimen of oseltamivir for postexposure prophylaxis of influenza in wards. J Hosp Infect. 2016 Oct;94(2):150-3. doi: 10.1016/j.jhin.2016.05.012. Epub 2016 May 25.
- Derived from this study: PubMed 38902383Wrotek A, Jackowska T. A noninferiority randomized open-label pilot study of 3- versus 7-day influenza postexposure prophylaxis with oseltamivir in hospitalized children. Sci Rep. 2024 Jun 20;14(1):14192. doi: 10.1038/s41598-024-65244-5.
- Three-day regimen of oseltamivir for postexposure prophylaxis of influenza in wards.Link provided by the sponsor.
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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.
August E. Wrotek, MD PhD principal investigator
The Centre of Postgraduate Medical Education
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 3 days and Oseltamivir 7 days in people with Influenza and Exposure, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Sep 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact August E. Wrotek, MD, PhD ((+48)228641167, august.wrotek@bielanski.med.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postexposure chemoprophylaxis efficacy (time frame: up to 7 days after PEP has finished). The study lists 3 primary outcomes in all. 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 NCT04297462, which also lists 2 linked publications.
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 9 Sep 2020.