Prevention of Borrelia infection and prevention of borreliosis through application of a gel, within three days, on the site of the tick bite

• Conditions: yme borreliosis; MedDRA version: 14.1Level: LLTClassification code 10067559Term: Lyme borreliosisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-000117-39-AT
• Lead Sponsor: Ixodes AG.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-20
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3300

Inclusion Criteria

1. Signed written informed consent by the subject before any study procedure is performed.
2. Males or females aged = 18 years and < 80 years at screening.
3. Subjects bitten by one tick (single bite), who have extracted the tick from the skin and collected such tick or parts of the tick (e.g. hypostom), or have the tick or parts of the tick still attached to the skin, and are willing to hand it over.
4. Subjects able to receive the first study treatment administration at the latest on the 4th calendar day from the day the tick bite was first noticed (note: the day the tick bite was first noticed being counted as the first calendar day).
5. Are neither pregnant, nor breast-feeding and do not plan to become pregnant during the study. Females with childbearing potential must undergo a urine pregnancy test at screening. Please note that female subjects who have had a hysterectomy or are postmenopausal for longer than 2 years are not considered as being of childbearing potential. Pregnant or breast feeding females, or women planning to become pregnant during the study cannot participate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

1. Subjects who have treated the site of the index tick bite with a topical formulation of an antibiotic other than SHB004 gel. Administration of a topical antibiotic other than SHB004 outside the area of tick bite is allowed (e.g. ophthalmic or otic applications, etc).
2. Subjects who received parenteral or oral antibiotic treatment within 10 days prior to enrollment.
3. Subjects who have a skin score according to Appendix 1 of this protocol grading 3 or worse at baseline.
4. Subjects with a history of allergic reaction or hypersensitivity to macrolide antibiotics (e.g. erythromycin, azithromycin) characterized e.g. by rash, itching, difficulty in breathing or anaphylaxis.
5. Subjects with a history of autoimmune diseases (e.g. rheumatoid arthritis or lupus erythematosus), history or clinical signs of syphilis, active herpes virus infection, subjects under immunosuppressive therapy (prescription drugs only), collagen vascular or immunodeficiency disease, or with a known active infectious mononucleosis (please note, that subjects reporting a past infection are not excluded, only those reporting a current infection).
6. Concurrent systemic steroid therapy. Inhaled steroids are allowed. Topical steroids are allowed when applied at least 10 cm apart from the index tick bite site.
7. Treatment with systemic steroids, other immunomodulatory drugs, or cytostatics within 30 days before enrollment.
8. History of Borreliosis / Lyme disease during the previous 12 months or positive test for antibodies against Borrelia s.l. (seroconverted) as assessed within the last two years prior to enrollment (only the most recent antibody test has to be taken into account; if this latest test is negative the subject is not to be excluded for this reason).
9. Subjects presenting with multiple tick bites at screening/baseline visit.
10. Subjects unable to spot the site of the index tick bite at screening/baseline visit.
11. Subjects who have a history of one or more tick bites within 60 days prior to randomization (except for the current tick bite qualifying for this study).
12. Concurrent tick-borne diseases, such as babesiosis or ehrlichiosis.
13. Any other drug allergy or condition or significant medical problem which in the opinion of the investigator places the subject at unacceptable risk or does not allow the subject to follow study procedures as planned.
14. Have received treatment with any other investigational drug, and/or have participated in another clinical study within 30 days before screening.
15. Are pregnant or a nursing mother.
16. Have a history of, or known current problems with drug or alcohol abuse. (Subject with a history of abuse [drug and/or alcohol], but who have been observing a strict abstinence for at least 1 year will be allowed to participate).
17. Have a history or suspicion of unreliability, poor cooperation or non-compliance with medical treatment.
18. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confused state of the subject.
19. Have previously been enrolled in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified