Lyme disease MedDRA version: 14.1 Level: PT Classification code 10025169 Term: Lyme disease System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Sponsors
National Institute of Health and the Environment (Dutch acronym: RIVM)
Eligibility
Sex/Gender
All
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. Are the trial subjects under 18? yes Number of subjects for this age range: 350 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 750
Exclusion criteria
Exclusion criteria: - are unable to give informed consent or do not have a thorough command of the Dutch language. Persons who: - report other tick bites in the three months before inclusion. - have a contra indication for treatment with doxycycline (including pregnancy). - are – at the moment inclusion – not able to take prophylaxis within 72 hours after removal of the tick
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of antibiotic prophylaxis after a tick bite in the Dutch setting in relation to Borrelia infection of the tick, tick engorgement and attachment time.;Secondary Objective: (1) to assess the reduction in NNT when only prescribing prophylaxis if the tick is infected and the engorgement or attachment time is above a certain threshold. (2) to assess whether the efficacy of antibiotic prophylaxis after a tick bite is different for children than for adults (8-17 yrs of age vs 18 yrs and older). (3) to distinguish between prophylaxis efficacy for preventing early Lyme disease and more severe and/or chronic manifestations (4) to determine the risk of adverse events (AEs) due to taking prophylaxis. ;Primary end point(s): Erythema migrans and other diagnosed manifestations of Lyme disease (i.e. other skin manifestations, ocular manifestations, neuroborreliosis, Lyme arthritis, Lyme carditis and chronic complaints), in relation to receiving prophylaxis and the tick screening results (i.e. tick infection with Borrelia, engorgement and attachment time). ;Timepoint(s) of evaluation of this end point: During any point of the follow-up period of 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The number of participants that develop AEs in the month after taking the prophylaxis. Scores for other 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. Treatment of reported erythema migrans and other Lyme manifestations. Development of chronic complaints such as fatigue, headache, arthalgia, cognitive disturbances.;Timepoint(s) of evaluation of this end point: During any point of the follow-up period of 18 months. | — |
Countries
Netherlands
Contacts
Public ContactSecretariat Epid. and Surveillance
National Institute of Health and the Environment (Dutch acronym: RIVM)
Outcome results
None listed