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Status unknownNCT04223544Updated Jan 10, 2020

Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Healthcare Workers

An observational study in Influenza, Vaccination and Attitude of Health Personnel, sponsored by Wroclaw Medical University. Status unknown at 1 site in Poland. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Wroclaw Medical University · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
250
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Influenza
  • Vaccination
  • Attitude of Health Personnel

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Keywords

  • Influenza
  • Vaccination Coverage Rate
  • Healthcare Workers
  • General Practice
  • Point of Care Testing
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 250 is below the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthcare workers of selected General Practices or hospitals wards: doctors, nurses, midwives

Eligibility criteria

Inclusion Criteria:

  • Healthcare worker of selected General Practices or hospitals wards
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • GPs Healthcare Workers

    Diagnostic Test: Influenza POC and laboratory testing

  • Hospital Healthcare Workers

    Diagnostic Test: Influenza POC and laboratory testing

Interventions

  • Diagnostic testInfluenza POC and laboratory testing

    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).

06

What researchers measure

Primary outcomes

  1. Incidence of Influenza Infections

    Incidence of influenza will be determined of results of POC and laboratory testing

    Time frame: January-March 2020

  2. Vaccination Coverage Rate

    Vaccination Coverage Rate will be determined of survey questionnaires

    Time frame: January-March 2020

07

Study locations

1 of 1 sites recruiting
  • Family Medicine Department of Wroclaw Medical University
    Wrocław, 51-141, Poland
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04223544
Lead sponsor
Wroclaw Medical University
Responsible party
Michał Jędrzejek (Principal Investigator, Wroclaw Medical University) — Principal investigator
First posted
Jan 10, 2020
Start date
Jan 13, 2020 (estimated)
Primary completion
Apr 3, 2020 (estimated)
Completion
Apr 3, 2020 (estimated)
Last update
Jan 10, 2020

Study contacts

Michal Jedrzejek
Contact
michaljedrzejek@gmail.com
+48691399392
Michal Jedrzejek
Contact
+48691399392
Michal Jedrzejek
principal investigator · Family Medicine Department of Wroclaw Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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