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

• Sponsor: Wroclaw Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04223544
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 2.7
• Patients Per Site Per Month: 93.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Influenza; Vaccination; Attitude of Health Personnel	Diagnostic Test: Influenza POC and laboratory testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Hospital and GPs Healthcare Workers During the 2019/2020 Epidemic Season
• Anticipated Study Start Date: Jan 13, 2020
• Anticipated Primary Completion Date: Apr 3, 2020
• Anticipated Study Completion Date: Apr 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
GPs Healthcare Workers	Diagnostic Test: 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).
Hospital Healthcare Workers	Diagnostic Test: 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).

Outcome Measures

Primary Outcome Measures

1. Incidence of Influenza Infections [January-March 2020]

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

2. Vaccination Coverage Rate [January-March 2020]

   Vaccination Coverage Rate will be determined of survey questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthcare worker of selected General Practices or hospitals wards

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Family Medicine Department of Wroclaw Medical University	Wrocław		Poland	51-141

Sponsors and Collaborators

• Wroclaw Medical University

Investigators

• Principal Investigator: Michal Jedrzejek, Family Medicine Department of Wroclaw Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michał Jędrzejek, Principal Investigator, Wroclaw Medical University
• ClinicalTrials.gov Identifier: NCT04223544
• Other Study ID Numbers: 779/2019
• First Posted: Jan 10, 2020
• Last Update Posted: Jan 10, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michał Jędrzejek, Principal Investigator, Wroclaw Medical University: Influenza; Vaccination Coverage Rate; Healthcare Workers; General Practice; Point of Care Testing
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Jan 10, 2020