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Tick Test and Prophylaxis Proof

Tick Test and Prophylaxis Proof - TT and PP

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39797
Enrollment
4500
Registered
2012-12-13
Start date
2013-04-12
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Borrelia infection Lyme disease

Interventions

The participants in the treatment group will take a single dose of doxycycline in a dosage of 200 mg for adults and children of 8 years and older and above 50 kg body weight
in a dosage of 4 mg/kg doxycycline for children of 8 years and older and below 50 kg body weight.

Sponsors

RIVM
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Persons who: - are 8 yrs and older - are not pregnant - report a recent tick bite on the webportal Tekenradar.nl * i.e. at the moment of inclusion they are able to take prophylaxis within 72 hrs after removal of the tick. - are willing to send the tick to the RIVM.

Exclusion criteria

Exclusion criteria: Persons who: - are unable to give informed consent or do not have a thorough command of the Dutch language. - report other tick bites in the three months before inclusion. - have a contra indication for treatment with doxycycline (including pregnancy and earlier allergic reactions to tetracyclines). - are * at the moment inclusion * not able to take prophylaxis within 72 hours after removal of the tick

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the prophylaxis efficacy, i.e. the relative risk (RR) reduction for developing Lyme disease after a tick bite and the NNT to prevent one case of Lyme disease. The tick screening results will be used to assess the reduction in NNT when only prescribing prophylaxis if the tick is infected and the engorgement or attachment time are above a certain threshold.

Secondary

MeasureTime frame
The number of participants that develop AEs in the month after taking the prophylaxis. Scores for epidemiological risk factors for acquiring tick bites and developing Lyme disease such as exposure to ticks in daily life, participants* activities when acquiring the tick bite, area of acquiring the tick bite, prevention of tick bites. Differences in NNT for children and adults.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)