- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223544
Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Healthcare Workers
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:
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Wrocław, Poland, 51-141
- Recruiting
- Family Medicine Department of Wroclaw Medical University
-
Contact:
- Michal Jedrzejek
- Phone Number: +48691399392
- Email: michaljedrzejek@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare worker of selected General Practices or hospitals wards
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GPs Healthcare Workers
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Influenza Infections
Time Frame: January-March 2020
|
Incidence of influenza will be determined of results of POC and laboratory testing
|
January-March 2020
|
|
Vaccination Coverage Rate
Time Frame: January-March 2020
|
Vaccination Coverage Rate will be determined of survey questionnaires
|
January-March 2020
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michal Jedrzejek, Family Medicine Department of Wroclaw Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 779/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.