NCT04223544

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 6, 2020

Last Update Submit

January 8, 2020

Conditions

Keywords

InfluenzaVaccination Coverage RateHealthcare WorkersGeneral PracticePoint of Care Testing

Outcome Measures

Primary Outcomes (2)

  • Incidence of Influenza Infections

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

    January-March 2020

  • Vaccination Coverage Rate

    Vaccination Coverage Rate will be determined of survey questionnaires

    January-March 2020

Study Arms (2)

GPs Healthcare Workers

Diagnostic Test: Influenza POC and laboratory testing

Hospital Healthcare Workers

Diagnostic Test: Influenza POC and laboratory testing

Interventions

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).

GPs Healthcare WorkersHospital Healthcare Workers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Healthcare worker of selected General Practices or hospitals wards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medicine Department of Wroclaw Medical University

Wroclaw, 51-141, Poland

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Michal Jedrzejek

    Family Medicine Department of Wroclaw Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Jedrzejek

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 10, 2020

Study Start

January 13, 2020

Primary Completion

April 3, 2020

Study Completion

April 3, 2020

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations