InfluenzaNCT04223544
Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Healthcare Workers
An observational study of Influenza and Vaccination, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The main aim of research is to determine of the prevalence of influenza virus and influenza vaccination coverage rate among hospital and GPs healthcare workers. Course of research: Participation in the study is voluntary and carried out after the consent of the examined person. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza, Vaccination, Attitude of Health Personnel
- What is being tested?
- Influenza POC and laboratory testing
- How many people
- 250 participants
- Where
- 1 sitePoland
- Study dates
- 13 Jan 2020to 3 Apr 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthcare workers of selected General Practices or hospitals wards: doctors, nurses, midwives
Who may be able to join
- Healthcare worker of selected General Practices or hospitals wards
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Michal Jedrzejek contact
Poland1 site, 1 recruiting
- Recruiting
Family Medicine Department of Wroclaw Medical University
Wroclaw, 51-141
Michal Jedrzejek, +48691399392, michaljedrzejek@gmail.com
About this study
Official title: Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Hospital and GPs Healthcare Workers During the 2019/2020 Epidemic Season
The main aim of research is to determine of the prevalence of influenza virus and influenza vaccination coverage rate among hospital and GPs healthcare workers.
Course of research:
Read more
Participation in the study is voluntary and carried out after the consent of the examined person. The examination consists of: 1) completing the questionnaire and 2) taking the throat swab twice by the researcher. Two throat swab samples will be taken at the same time. Both samples will be used for virological examination to determine the presence of influenza virus material using non-invasive tests: one sample will be analyzed by a quick 'on-site' test - Flu SensDx kit, while the other sample will be transported to the laboratory, where the reverse transcriptase polymerase chain reaction (RT-PCR) - reference method - will be performed to confirm the presence of influenza genetic material. Swabs are planned to be collected during the 2019/2020 influenza epidemic season (January-March).
In the last stage of the study, the results obtained from the survey questionnaire and the results of virological tests will be subject to statistical analysis and based on the data obtained, conclusions will be drawn from the study, indicating their practical application.
The results obtained from this study will be used to develop a quality improvement program to control influenza virus infection, which will improve the safety of both patients and medical staff.
- Conditions
- Influenza, Vaccination, Attitude of Health Personnel
- Being tested
- Influenza POC and laboratory testing
- Keywords
- Influenza, Vaccination Coverage Rate, Healthcare Workers, General Practice, Point of Care Testing
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza POC and laboratory testingDiagnostic test
Participation in the study is voluntary and carried out after the consent of the examined person. The examination consists of: 1) completing the questionnaire and 2) taking the throat swab twice by the researcher. Two throat swab samples will be taken at the same time. Both samples will be used for virological examination to determine the presence of influenza virus material using non-invasive tests: one sample will be analyzed by a quick 'on-site' test - Flu SensDx kit, while the other sample will be transported to the laboratory, where the reverse transcriptase polymerase chain reaction (RT-PCR) - reference method - will be performed to confirm the presence of influenza genetic material. Swabs are planned to be collected during the 2019/2020 influenza epidemic season (January-March).
| Study group | Role | What they receive |
|---|---|---|
| GPs Healthcare Workers | Not described Receives: Diagnostic Test: Influenza POC and laboratory testing | |
| Hospital Healthcare Workers | Not described Receives: Diagnostic Test: Influenza POC and laboratory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Influenza Infections
Incidence of influenza will be determined of results of POC and laboratory testing
Measured: January-March 2020
Vaccination Coverage Rate
Vaccination Coverage Rate will be determined of survey questionnaires
Measured: January-March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start13 Jan 2020 (estimated)
- Primary completion3 Apr 2020 (estimated)
- Study completion3 Apr 2020 (estimated)
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 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Jędrzejek, Wroclaw Medical University
- Investigators
- Michal Jedrzejek, Principal investigator, Family Medicine Department of Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223544
- Sponsor's protocol ID
- 779/2019
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jedrzejek MJ, Mastalerz-Migas A, Janicka P. Incidence of Influenza Virus Infection among Wroclaw's Healthcare Workers in Pre-COVID-19 2019-2020 Influenza Season Using Novel Flu SensDx Device. Int J Environ Res Public Health. 2022 Mar 8;19(6):3159. doi: 10.3390/ijerph19063159.
PubMed 35328847
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Hospital and GPs Healthcare Workers During the 2019/2020 Epidemic Season
- ClinicalTrials.gov ID
- NCT04223544
- Acronym / sponsor ID
- 779/2019
- Conditions
- Influenza, Vaccination, Attitude of Health Personnel
- Keywords
- Influenza, Vaccination Coverage Rate, Healthcare Workers, General Practice, Point of Care Testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (estimated)
- Primary completion
- 3 Apr 2020 (estimated)
- Study completion
- 3 Apr 2020 (estimated)
- First posted
- 10 Jan 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.
The main aim of research is to determine of the prevalence of influenza virus and influenza vaccination coverage rate among hospital and GPs healthcare workers.
Course of research:
Participation in the study is voluntary and carried out after the consent of the examined person. The examination consists of: 1) completing the questionnaire and 2) taking the throat swab twice by the researcher. Two throat swab samples will be taken at the same time. Both samples will be used for virological examination to determine the presence of influenza virus material using non-invasive tests: one sample will be analyzed by a quick 'on-site' test - Flu SensDx kit, while the other sample will be transported to the laboratory, where the reverse transcriptase polymerase chain reaction (RT-PCR) - reference method - will be performed to confirm the presence of influenza genetic material. Swabs are planned to be collected during the 2019/2020 influenza epidemic season (January-March).
In the last stage of the study, the results obtained from the survey questionnaire and the results of virological tests will be subject to statistical analysis and based on the data obtained, conclusions will be drawn from the study, indicating their practical application.
The results obtained from this study will be used to develop a quality improvement program to control influenza virus infection, which will improve the safety of both patients and medical staff.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPs Healthcare Workers | – | Diagnostic Test: Influenza POC and laboratory testing |
| Hospital Healthcare Workers | – | Diagnostic Test: Influenza POC and laboratory testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthcare workers of selected General Practices or hospitals wards: doctors, nurses, midwives
Key inclusion criteria (1 listed)
- Healthcare worker of selected General Practices or hospitals wards
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Influenza POC and laboratory testingParticipation in the study is voluntary and carried out after the consent of the examined person. The examination consists of: 1) completing the questionnaire and 2) taking the throat swab twice by the researcher. Two throat swab samples will be taken at the same time. Both samples will be used for virological examination to determine the presence of influenza virus material using non-invasive tests: one sample will be analyzed by a quick 'on-site' test - Flu SensDx kit, while the other sample will be transported to the laboratory, where the reverse transcriptase polymerase chain reaction (RT-PCR) - reference method - will be performed to confirm the presence of influenza genetic material. Swabs are planned to be collected during the 2019/2020 influenza epidemic season (January-March). | Diagnostic test | GPs Healthcare Workers, Hospital Healthcare Workers |
Primary outcome
Incidence of Influenza Infections
Time frame: January-March 2020
Incidence of influenza will be determined of results of POC and laboratory testing
Vaccination Coverage Rate
Time frame: January-March 2020
Vaccination Coverage Rate will be determined of survey questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 35328847Jedrzejek MJ, Mastalerz-Migas A, Janicka P. Incidence of Influenza Virus Infection among Wroclaw's Healthcare Workers in Pre-COVID-19 2019-2020 Influenza Season Using Novel Flu SensDx Device. Int J Environ Res Public Health. 2022 Mar 8;19(6):3159. doi: 10.3390/ijerph19063159.
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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.
Michal Jedrzejek contact
Michal Jedrzejek principal investigator
Family Medicine Department of Wroclaw Medical University
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 and Vaccination, run by Wroclaw Medical University 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 1 inclusion and 0 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 10 Jan 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 Michal Jedrzejek (+48691399392, michaljedrzejek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Influenza Infections (time frame: January-March 2020). 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?
On the ClinicalTrials.gov record for NCT04223544, 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 10 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.