Antibiotic prophylaxis reduces the risk of Lyme disease after a tick bite in the Dutch setting, in relation to tick infection, tick engorgement and attachment time.
ID
Bron
Verkorte titel
Aandoening
Lyme disease (Lyme ziekte)
tick bite (tekenbeet)
prophylaxis (profylaxe)
antibiotics (antibiotica)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Efficacy of prophylaxis, i.e. the relative risk (RR) reduction for developing Lyme disease after a tick bite and the Number Needed to Treat (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.
Achtergrond van het onderzoek
In the last 15 years, the number of cases of early Lyme disease in the Netherlands has tripled to 22,000 per year, posing an increasing public health burden. Antibiotic treatment of early Lyme disease is crucial as it can prevent the development of late and more severe disease stages. However, infections can initially remain undetected due to the diverse and often ambiguous nature of clinical manifestations of Lyme disease. Furthermore laboratory diagnostics are not always capable of detecting an early infection.
In the US, prophylactic antibiotic treatment after a tick bite has been shown to prevent most Lyme disease. It has not been investigated whether prophylaxis is effective in the Netherlands whereas transmission dynamics regarding ticks and Borrelia species are different from the US. With 1.1 million tick bites per year the recommendation of prophylaxis would result in very large numbers of patients treated with prophylaxis.
For a future evidence-based guideline on prophylaxis, its efficacy in the Dutch setting should be investigated. It should also be investigated to what extent the NNT can be reduced by using tick-screening criteria (tick infection, tick engorgement and attachment time) to assess the risk of Lyme disease after each tick bite. If this tick-screening and subsequent preventive intervention procedure proves successful, most Lyme disease is preventable with minimal use of antibiotics.
Doel van het onderzoek
Antibiotic prophylaxis reduces the risk of Lyme disease after a tick bite in the Dutch setting, in relation to tick infection, tick
engorgement and attachment time.
Onderzoeksopzet
After 1 week, 1 month, and every 3 months up to 18 months of f.u. the subjects are requested to complete a questionnaire regarding symptoms of Lyme disease.
At week 1 and month 1 subjects in the treatment group are also asked about Adverse Events after antibiotic use.
Onderzoeksproduct en/of interventie
A single dose of 200 mg doxycycline for adults and children > 8 years and older (if body weight < 50 kg, the dose is adjusted to 4 mg/kg body weight) within 72 hours after tick removal.
The control group receives no treatment.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 8 yrs and older;
2. Not pregnant;
3. 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;
4. Willing to send the tick to the RIVM.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Not able to give informed consent or do not have a thorough command of the Dutch language;
2. Report other tick bites in the three months before inclusion;
3. Contra-indication for treatment with doxycycline (including pregnancy and earlier allergic reactions to
tetracyclines);
4. Not able to take prophylaxis within 72 hours after removal of the tick at the moment inclusion.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3787 |
| NTR-old | NTR3953 |
| CCMO | NL42713.094.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39797 |