To gain insight in the risk of transmission of tick-borne micro-organisms Borrelia, Ehrlichia, Rickettsia and Babesia to humans and to gain insight in risk factors.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- seroconversion of antibodies against Borrelia, by means of comparison of
nul-serology with serology after 10 to 12 weeks.
- microbiological identification of Borrelia, Ehrlichia, Rickettsia en Babesia
in ticks by means of PCR.
Secondary outcome
- seroconversion of antibodies against Ehrlichia, Rickettsia en Babesia, by
means of comparison of nul-serology with serology after 10 to 12 weeks.
- microbiological identification of Ehrlichia, Rickettsia en Babesia in blood
by means of PCR.
Background summary
The last ten years we have observed an increase of hospitalisations for Lyme
disease and a threefold increase was seen of general practitioner consults for
tick bites and erythema migrans. Study results of ticks collected in the field
in 2001, 2002, 2003 and 2004 showed that ticks in the Netherlands were not only
contaminated with Borrelia, but also with other tick-borne micro-organisms such
as Ehrlichia, Rickettsia en Babesia. Like in other European countries, this
suggests an increasing risk of ticks being contaminated with these
micro-organisms. This poses an increasing but unknown threat for public health.
Study objective
To gain insight in the risk of transmission of tick-borne micro-organisms
Borrelia, Ehrlichia, Rickettsia and Babesia to humans and to gain insight in
risk factors.
Study design
Patients will be invited to the study by their own general practitioner (GP)
when they consult their GP for a tick bite or erythema migrans.
If the tick was taken by the participant, it's sent to the RIVM for
determination of micro-organisms.
A first questionnaire gives insight into risk factors for tick bites and Lyme
disease.
7 ml blood for nul-serology (Borrelia), and 5 ml blood for PCR are collected
by means of a first venapuncture.
The participant returns to the GP in 10 to 12 weeks to receive a second study
kit.
A second questionnaire gives insight into the course of illness since the first
consult.
7 ml blood for serology (Borrelia) is collected by means of a first
venapuncture, to compare for seroconversion with the nul-serology.
The GP of a participant will only receive testresults in case of
seroconversion, on condition that the participant has provided permission. In
all other cases no test results will be communicated, unless the GP explicitly
asks for it.
Study burden and risks
The participant will be asked twice to fill in a questionnaire and to give
blood twice(a total of 2 tubes of 7 ml, and one tube of 5 ml)
Total time investment for the participant: 1 hour.
Postbus 1
3720 BA Bilthoven
Nederland
Postbus 1
3720 BA Bilthoven
Nederland
Listed location countries
Age
Inclusion criteria
Patiƫnts with a tick bite, who still have the tick.
Patiƫnts with an erythema migrans
Exclusion criteria
Not having a tick bite, a tick or an erythema migrans
Being younger than 6 yrs of age
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL16189.041.07 |