Lyme disease
Conditions
Interventions
None listed
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Males and females *18 years of age with suspected Lyme disease. 2. Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study. 3. Participants who are willing and able to comply with scheduled visits and study procedures.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be included in the study: 1. Previous vaccination with a licensed Lyme disease vaccine or previous participation in a clinical trial involving the administration of a Lyme disease vaccine candidate. 2. Use of a systemic antimicrobial for any indication or topical antimicrobial at the rash site initiated greater than 2 days prior to enrolment in the study. 3. Any chronic skin condition that the investigator feels may be confounding. 4. Known or suspected defect of the immune system, such as congenital or acquired immunodeficiency, including poorly controlled infection with human immunodeficiency virus or receipt of immunosuppressive therapy within 30 days prior to Visit 1. Use of systemic corticosteroids (*20 mg a day for *10 days within the prior 4 weeks) is prohibited. Nonsystemic corticosteroid use, such as topical and inhaled steroids, is permitted. 5. Received blood or blood-derived products (eg, plasma or intravenous immunoglobulin) within 6 months prior to Visit 1 or planned receipt during the study. 6. Contraindication to skin biopsies or receiving anticoagulant medication, such as heparin, LMW heparin, warfarin, antiplatelets, novel oral anticoagulants (eg, apixaban), antiplatelet medication (eg, clopidogrel), or medications known to cause thrombocytopenia (unless considered safe to stop and washout for the duration of the study), prior to Visit 1 and through the last study visit. NSAIDs and low-dose acetylsalicylic acid will not be considered antiplatelet therapy. 7. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction. 8. Monoclonal antibody therapy within the 4 months before Visit 1 and through the last study visit. 9. Any acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. 10. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who had clinical specimen(s) collected at each specified visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants presenting with various manifestations of suspected Lyme disease. | — |
Countries
Netherlands
Outcome results
None listed