Evaluation and Follow-up of People With Tick-borne Diseases

  • End date
    May 31, 2030
  • participants needed
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 19 September 2021
antibiotic therapy
tick-borne diseases



Lyme disease is the most common tick-borne disease in the United States, but other diseases transmitted by ticks have also been on the rise in recent years. Early symptoms of a tickborne disease include fever, headache, fatigue and possible rash. Researchers want to collect information and samples from people with Lyme disease and other tick-borne illnesses to better understand and diagnose these diseases.


To evaluate and follow people with tick-borne diseases to help researchers learn more about these infections.


People ages 18 and older who have or are suspected of having a tick-borne infection.


Participants will have an initial visit, and visits about 1, 6, and 12 months later. The visits can include a physical exam, blood tests, collection of blood, urine and saliva samples for research, and filling out health-related questionnaires. Participants who have the rash of Lyme disease may be invited to have up to 3 skin punch biopsies of the rash for research.


Lyme disease is a multisystem illness caused by the spirochete Borrelia burgdorferi and it is the most common vector-borne illness in the United States. Tick-borne disease cases reported to the Center for Disease Control and Prevention (CDC) have been on the rise with over 59,000 cases reported in 2017. This protocol is designed to collaborate with University of Maryland School of Medicine for the purpose of recruiting and enrolling patients with Lyme disease and other tickborne illnesses. This is a natural history study which has the objective of developing a rigorously defined population of patients with Lyme disease and other tick-borne illnesses, per CDC case definitions, to serve as the basis for research in multiple aspects of the infections. These research sub-projects have emphasis in exploring the biological markers of tick-borne infections, developing new diagnostic tests for these infections, assessing the clinical course and outcome of patients with these tick-borne infections, and defining the immunological response to the pathogens.

Condition Lyme Disease, Lyme Disease Vaccine, Tick-Borne Disease, tick-borne diseases
Clinical Study IdentifierNCT04318925
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on19 September 2021


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Inclusion Criteria

Clinical diagnosis of suspected, confirmed, or probable LB or other TBD per CDC case definitions
Has not received antibiotic therapy for tick-borne disease for more than 2 weeks
Age >=18 years
Able to provide informed consent
Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other disorders

Exclusion Criteria

Post-treatment Lyme disease syndrome
Women who report they are pregnant
Any other condition or history of unacceptably poor compliance that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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