E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10025169 |
E.1.2 | Term | Lyme disease |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
(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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During any point of the follow-up period of 18 months. |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During any point of the follow-up period of 18 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last questionnaire being completed by the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |