We aim to determine the impact and seriousness of other TBDs in the Netherlands by measuring the prevalence and describing the clinical picture and the course of different other TBDs.
ID
Source
Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
virale infectieziekten, Rickettsia infectieziekten, parasitaire aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. 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.
2. 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 specialist(s) and measured by laboratory tests, PCR, serological and
culture analyses in both cases and controls
Secondary outcome
To obtain clinical isolates of the different TBPs, and other materials from
patients with well defined other TBDs, for further research and
development/improvement of diagnostic tests.
Background summary
Tick-borne pathogens (TBPs) other than Borrelia burgdorferi s.l. * the
causative agent of Lyme Borreliosis - and tick-borne encephalitis virus (TBEV),
are common in Ixodes ticks in the Netherlands. How often these (potential)
pathogens actually lead to disease is unknown and proper diagnostic tools are
lacking. These problems lead to the initiation of the *Ticking on Pandora*s
Box* study. This study investigates how often Borrelia miyamotoi, Anaplasma
phagocytophilum, Neoehrlichia mikurensis, Rickettsia species or Babesia species
can cause an acute febrile illness after tick-bite. In addition, the obtained
materials will be used to diagnostic modalities to detect TBPs. The data and
insights from our study can be used to develop new national guidelines on TBDs.
Study objective
We aim to determine the impact and seriousness of other TBDs in the Netherlands
by measuring the prevalence and describing the clinical picture and the course
of different other TBDs.
Study design
The current study is an prospective case-control study. Individuals who develop
fever within 4 weeks after tick-bit are eligible for participation, if no other
probable cause of the fever is found. Follow-up of participants is 12 months.
From study participants digital questionnaires are obtained (at start and after
3, 6, 9 and 12 months), a urine sample is collected (at start), a skin biopsy
is taken (at start, if a skin lesion is present and if separate consent is
provided), and blood samples are taken (at start and after 4 weeks). Also,
participants can send in the tick that has bitten them (at start). The tick and
bodily materials are analyzed using existing and experimental tests for
tick-borne pathogens (TBPs). The data from the questionnaires will be used to
link symptoms to specific illnesses and to determine the course of these other
TBDs. The results of this study will make important contributions to insights
into the prevalence, clinical manifestation, diagnostics and possible treatment
of TBPs in the Netherlands, which can be used for the modification of existing
guidelines.
Study burden and risks
There is a minimal burden and negligible risk associated with study
participation. Drawing blood can be accompanied with local pain and a hematoma,
without the loss of functioning. Skin biopsy has a risk of local pain, a
hematoma or a local skin infection. The local pain is reduced by local
anesthesia (injection) and the risk for infection by local disinfection and
sterile bandages for 48 hours after biopsy. Urine sampling has a minimal burden
and does not bare any risks. The burden of time spent on the participation of
this study is minimal (2-4 hours in one year).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Cases:
- Subjects are 16 years and older;
- Subjects report a tick-bite acquired in the last 2 months;
- Subjects develop fever (defined as * 38.0 °C) within 4 weeks after the
tick-bite;
- The temperature is measured rectally, orally, axillary or tympanic;
- Subjects do not have evident signs or symptoms of another cause of the fever
besides a TBD;
- Subjects live or stay in the Netherlands;
- Subjects are able to give informed consent and have a thorough command of the
Dutch language., Controls:
- Subjects are 16 years and older;
- Subjects report a tick-bite acquired in the last 2 months;
- Subjects do not have a temperature > 37.3 °C within 4 weeks after the
tick-bite;
- Subjects do not have evident signs or symptoms of any infectious disease;
- Subjects live or stay in the Netherlands;
- Subjects are able to give informed consent and have a thorough command of the
Dutch language.
Exclusion criteria
Cases: Subjects, who
- Are 15 years or younger;
- Report a tick-bite acquired more than 2 months ago;
- Develop fever more than 4 weeks after tick-bite;
- Have not measured a temperature over 38.0 °C;
- Have evident signs and symptoms pointing towards another cause of the fever
than a TBD;
- Live or stay outside of the Netherlands during the course of the study;
- Are unable to give informed consent or do not have a thorough command of the
Dutch language., Controls: Subjects, who
- Are 15 years or younger;
- Report a tick-bite acquired more than 2 months ago;
- Develop a measured temperature * 37.3 °C within 4 weeks after the tick-bite;
- Have evident signs or symptoms of any infectious disease;
- Live or stay outside of the Netherlands during the course of the study;
- Are unable to give informed consent or do not have a thorough command of the
Dutch language.
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 | NL61446.094.17 |