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Ticking on Pandora's Box

Ticking on Pandora's Box: a prospective case-control study into ‘other’ tick-borne diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27838
Enrollment
350
Registered
2021-02-10
Start date
2018-04-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme borreliosis, anaplasmosis, babesiosis, Borrelia miyamotoi disease, neoehrlichiosis, rickettsiosis, tick-borne encephalitis virus

Interventions

None listed

Sponsors

ZonMW
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases (n=150) • Subjects are =16 years old; • Subjects report a tick-bite acquired within the last 2 months; • Subjects report an objectified (measured rectally, orally, axillary or tympanic) fever (defined as =38.0°C) within the last 4 weeks, developed in the course of 4 weeks after tick-bite; • Subjects live or stay in the Netherlands during the course of the study. Controls (n=200) • Subjects are =16 years old; • Subjects report a tick-bite acquired within the last 2 months; • Subjects frequency match to cases by gender, age, province of residence and month of tick-bite acquirement; • Subjects live or stay in the Netherlands during the course of the study.

Exclusion criteria

Exclusion criteria: Cases • Subjects with evident signs or symptoms of another cause of the fever besides a TBD; • Subjects unable to provide informed consent or do not have sufficient proficiency in the Dutch language. Controls • Subjects develop an objectified (measured rectally, orally, axillary or tympanic) temperature >37.3°C within 4 weeks after the tick-bite; • Subjects with evident signs or symptoms of a currant infectious disease; • Subjects unable to provide informed consent or do not have sufficient proficiency in the Dutch language.

Design outcomes

Primary

MeasureTime frame
The primary outcome measures the prevalence of the different TBDs tested in blood, urine, skin biopsy in a group of participants who develop fever within 4 weeks after tick-bite in the Netherlands, of whom other causes of the fever are excluded. This measurement will be compared to the prevalence of infection with the same TBPs between the different control groups.

Secondary

MeasureTime frame
The secondary outcomes measures the long term sequelae and the clinical manifestations of the different TBD’s. This will be obtained from the questionnaires and information from the treating physicians and measured by laboratory tests, culture, molecular and serological analyses in both cases and control groups. An additional aim is to obtain clinical isolates of the different TBPs, and other materials from patients with well-defined other TBDs, for further research and development, improvement or validation of diagnostic tests.

Contacts

Public ContactDieuwertje Hoornstra

Amsterdam UMC

d.hoornstra@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)