Influenza, HumanZOOISNCT05827601
Zoonotic Influenza Surveillance in Belgium
An observational study of Influenza, Human, run by Cyril Barbezange at 1 site in Belgium.
Trial summary
The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- respiratory specimen and serum
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2023to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Workers or volunteers of one of the targeted groups within the sites that accept to take part in the study
Who may be able to join
- worker or volunteer of one of the targeted groups at one of the selected sites and accepting to take part in the study
- to have regular contacts with animals within job/activity framework
- being committed to take the regular samples
Who cannot join
- people who had a broken nose might have difficulties to perform self-swabbing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Surveillance of Influenza Virus Zoonotic Transmission Events: a Pilot Study in Belgium
The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people.
Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans.
Read more
Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic.
As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.
- Conditions
- Influenza, Human
- Being tested
- respiratory specimen, serum
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory specimenDiagnostic test
participants will perform self-sampling with a nasopharyngeal swab
serumDiagnostic test
participants will be invited to get a blood sample taken by a general practitioner or to perform a self sampling of capillary blood
| Study group | Role | What they receive |
|---|---|---|
| Avian Influenza Outbreak Farms | People involved in outbreak management, ranging from poultry farm owners and their family to inspectors through veterinarians and cullers/cleaners, will be invited to take part in the study at the earliest step possible after outbreak detection. Self sampling by nasopharyngeal swab will be requested every 2 days during 2 weeks. Receives: Diagnostic Test: respiratory specimen; Diagnostic Test: serum | |
| Poultry Farm Sentinel Network | People working in poultry farms and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study.
anticipated: 15 Receives: Diagnostic Test: respiratory specimen | |
| Wild bird/life Rehabilitation Centre Sentinel Network | People working in wild bird/life rehabilitation centers and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study.
anticipated: 25 Receives: Diagnostic Test: respiratory specimen | |
| Pig Industry Veterinarian Sentinel Network | Veterinarians working in the pig industry and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study.
anticipated: 15 Receives: Diagnostic Test: respiratory specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sentinel participants positive for a non-seasonal influenza virus
result of RT-qPCR test to detect and characterize non-influenza viruses
Measured: every 2 weeks through study completion (December 2024)
Number of outbreak participants positive for a non-seasonal influenza virus
result of RT-qPCR test to detect and characterize non-influenza viruses
Measured: every 2 days during 2 weeks after enrollment
Secondary outcomes (1)
Number of outbreak participants with seroconversion against a non-seasonal influenza virus
result of inhibition of haemagglutination or seroneutralisation assay
Measured: at enrollment and about 4 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyril Barbezange
- Sponsor type
- Other government
- Collaborators
- Sciensano, Belgian Federal Public Service, Food Chain Safety and Environment, Agentschap Zorg en Gezondheid
- Responsible party
- Sponsor-investigator, Cyril Barbezange, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827601
- Sponsor's protocol ID
- ZOOIS-23-24
- Acronym
- ZOOIS
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance of Influenza Virus Zoonotic Transmission Events: a Pilot Study in Belgium
- ClinicalTrials.gov ID
- NCT05827601
- Acronym / sponsor ID
- ZOOIS / ZOOIS-23-24
- Conditions
- Influenza, Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cyril BarbezangeOther government
- Collaborators
- Sciensano, Belgian Federal Public Service, Food Chain Safety and Environment, Agentschap Zorg en Gezondheid
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Apr 2023 (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 project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people.
Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans.
Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic.
As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Avian Influenza Outbreak Farms | – | Diagnostic Test: respiratory specimen, Diagnostic Test: serumPeople involved in outbreak management, ranging from poultry farm owners and their family to inspectors through veterinarians and cullers/cleaners, will be invited to take part in the study at the earliest step possible after outbreak detection. Self sampling by nasopharyngeal swab will be requested every 2 days during 2 weeks. |
| Poultry Farm Sentinel Network | – | Diagnostic Test: respiratory specimenPeople working in poultry farms and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study. anticipated: 15 |
| Wild bird/life Rehabilitation Centre Sentinel Network | – | Diagnostic Test: respiratory specimenPeople working in wild bird/life rehabilitation centers and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study. anticipated: 25 |
| Pig Industry Veterinarian Sentinel Network | – | Diagnostic Test: respiratory specimenVeterinarians working in the pig industry and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study. anticipated: 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Workers or volunteers of one of the targeted groups within the sites that accept to take part in the study
Key inclusion criteria (3 listed)
- worker or volunteer of one of the targeted groups at one of the selected sites and accepting to take part in the study
- to have regular contacts with animals within job/activity framework
- being committed to take the regular samples
Key exclusion criteria (1 listed)
- people who had a broken nose might have difficulties to perform self-swabbing
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 |
|---|---|---|
| respiratory specimenparticipants will perform self-sampling with a nasopharyngeal swab | Diagnostic test | Avian Influenza Outbreak Farms, Pig Industry Veterinarian Sentinel Network, Poultry Farm Sentinel Network, Wild bird/life Rehabilitation Centre Sentinel Network |
| serumparticipants will be invited to get a blood sample taken by a general practitioner or to perform a self sampling of capillary blood | Diagnostic test | Avian Influenza Outbreak Farms |
Primary outcome
Number of sentinel participants positive for a non-seasonal influenza virus
Time frame: every 2 weeks through study completion (December 2024)
result of RT-qPCR test to detect and characterize non-influenza viruses
Number of outbreak participants positive for a non-seasonal influenza virus
Time frame: every 2 days during 2 weeks after enrollment
result of RT-qPCR test to detect and characterize non-influenza viruses
1 secondary outcome
Number of outbreak participants with seroconversion against a non-seasonal influenza virus
Time frame: at enrollment and about 4 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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?
An observational study of Influenza, Human, run by Cyril Barbezange at 1 site in Belgium.
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 1 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 8 Sep 2023. 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 Belgium. 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?
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?
Number of sentinel participants positive for a non-seasonal influenza virus (time frame: every 2 weeks through study completion (December 2024)). The study lists 2 primary outcomes in all. 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 8 Sep 2023.