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

NCT ID: NCT04223544

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-13

Study Completion Date

2020-04-03

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza Vaccination Attitude of Health Personnel

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GPs Healthcare Workers

Influenza POC and laboratory testing

Intervention Type DIAGNOSTIC_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).

Hospital Healthcare Workers

Influenza POC and laboratory testing

Intervention Type DIAGNOSTIC_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).

Interventions

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Influenza 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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Healthcare worker of selected General Practices or hospitals wards
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Michał Jędrzejek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Jedrzejek

Role: PRINCIPAL_INVESTIGATOR

Family Medicine Department of Wroclaw Medical University

Locations

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Family Medicine Department of Wroclaw Medical University

Wroclaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Michal Jedrzejek

Role: CONTACT

+48691399392

Michal Jedrzejek

Role: CONTACT

+48691399392

Facility Contacts

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Michal Jedrzejek

Role: primary

+48691399392

References

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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.

Reference Type DERIVED
PMID: 35328847 (View on PubMed)

Other Identifiers

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779/2019

Identifier Type: -

Identifier Source: org_study_id

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