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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05294003
Other study ID # P20.112
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 28, 2021
Est. completion date December 14, 2021

Study information

Verified date March 2022
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In August 2020, West Nile Virus (WNV) was isolated from a live common whitethroat for the first time in The Netherlands. Follow-up sampling showed that the virus could also be detected in mosquitos from the same location during at least a whole month of sampling. On 15 October 2020, one case of West Nile virus infection has been reported in a man who was likely infected in the Utrecht region. This is the first time that a locally acquired human case of WNV infection has been reported in The Netherlands. Six additional cases have been identified, one of which from the region Arnhem. West Nile virus infection is a mosquito-borne zoonosis. The disease, which has spread across the Northern Hemisphere in the past three decades, is now found on an annual basis in many European countries where the centre of gravity lies in Southern-European countries. Recently, WNV was reported for the first time in Germany. The virus is transmitted among birds through the bite of infected mosquitoes and incidentally infects humans and other mammals, such as horses. Around 80% of human WNV infections are asymptomatic. The most common clinical presentation is West Nile fever but, older people and immunocompromised persons are at higher risk of developing neuro-invasive disorders (West Nile neuroinvasive disease). Currently, there are no prophylaxis or specific treatment against the disease in humans. In addition, Usutu virus (USUV) was detected in The Netherlands in 2016. USUV is another flavivirus, related to WNV, and also capable of infecting humans. Disease associated with USUV infection in humans appears to be milder and only limited number of cases have been identified. During their bird catching activities, bird ringers are intensively exposed to mosquito bites at the natural habitat of the birds and at the same time of the day when mosquitoes are particularly active. The aim of this study is therefore to determine the prevalence of WNV and USUV serum antibodies in bird ringers in The Netherlands.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date December 14, 2021
Est. primary completion date September 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Carrying-out bird ringing activities during spring, summer or early autumn 2020 in The Netherlands Exclusion Criteria: - Not willing to participate in this study - Using medication interfering with antibodies production - Under 18 years of age

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Leiden University Medical Centre (LUMC) Leiden

Sponsors (5)

Lead Sponsor Collaborator
Leiden University Medical Center Erasmus Medical Center, Leiden University, Netherlands Institute of Ecology, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Gaibani P, Rossini G. An overview of Usutu virus. Microbes Infect. 2017 Jul - Aug;19(7-8):382-387. doi: 10.1016/j.micinf.2017.05.003. Epub 2017 Jun 8. Review. — View Citation

Oude Munnink BB, Münger E, Nieuwenhuijse DF, Kohl R, van der Linden A, Schapendonk CME, van der Jeugd H, Kik M, Rijks JM, Reusken CBEM, Koopmans M. Genomic monitoring to understand the emergence and spread of Usutu virus in the Netherlands, 2016-2018. Sci Rep. 2020 Feb 18;10(1):2798. doi: 10.1038/s41598-020-59692-y. — View Citation

Rijks JM, Kik ML, Slaterus R, Foppen R, Stroo A, IJzer J, Stahl J, Gröne A, Koopmans M, van der Jeugd HP, Reusken C. Widespread Usutu virus outbreak in birds in the Netherlands, 2016. Euro Surveill. 2016 Nov 10;21(45). pii: 30391. doi: 10.2807/1560-7917.ES.2016.21.45.30391. — View Citation

Sikkema RS, Schrama M, van den Berg T, Morren J, Munger E, Krol L, van der Beek JG, Blom R, Chestakova I, van der Linden A, Boter M, van Mastrigt T, Molenkamp R, Koenraadt CJ, van den Brand JM, Oude Munnink BB, Koopmans MP, van der Jeugd H. Detection of West Nile virus in a common whitethroat (Curruca communis) and Culex mosquitoes in the Netherlands, 2020. Euro Surveill. 2020 Oct;25(40). doi: 10.2807/1560-7917.ES.2020.25.40.2001704. Erratum in: Euro Surveill. 2020 Oct;25(43):. — View Citation

Ziegler U, Santos PD, Groschup MH, Hattendorf C, Eiden M, Höper D, Eisermann P, Keller M, Michel F, Klopfleisch R, Müller K, Werner D, Kampen H, Beer M, Frank C, Lachmann R, Tews BA, Wylezich C, Rinder M, Lachmann L, Grünewald T, Szentiks CA, Sieg M, Schmidt-Chanasit J, Cadar D, Lühken R. West Nile Virus Epidemic in Germany Triggered by Epizootic Emergence, 2019. Viruses. 2020 Apr 15;12(4). pii: E448. doi: 10.3390/v12040448. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of individuals with neutralising antibodies against WNV by region One blood sample collected between June and September 2021
Primary The proportion of individuals with neutralising antibodies against USUV by region One blood sample collected between June and September 2021
Secondary The proportion of individuals with IgM antibodies against WNV One blood sample collected between June and September 2021
Secondary The proportion of individuals with IgG antibodies against WNV One blood sample collected between June and September 2021
Secondary The proportion of individuals with IgM antibodies against USUV One blood sample collected between June and September 2021
Secondary The proportion of individuals with IgG antibodies against USUV One blood sample collected between June and September 2021
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