Evaluation and Follow-up of People With Tick-borne Diseases
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| ClinicalTrials.gov Identifier: NCT04318925 |
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Recruitment Status :
Recruiting
First Posted : March 24, 2020
Last Update Posted : June 16, 2021
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Background:
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.
Objective:
To evaluate and follow people with tick-borne diseases to help researchers learn more about these infections.
Eligibility:
People ages 18 and older who have or are suspected of having a tick-borne infection.
Design:
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.
| Condition or disease |
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| Lyme Disease Tick-Borne Disease |
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation and Follow-up of Patients With Tick-borne Diseases |
| Estimated Study Start Date : | June 21, 2021 |
| Estimated Primary Completion Date : | December 31, 2029 |
| Estimated Study Completion Date : | May 31, 2030 |
| Group/Cohort |
|---|
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1
Persons with diagnosed or suspected tick-borne disease age >=18 years
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- Define percentage of participants with suspected, probable, or confirmed TBD, as defined by the CDC case definitions and TBD testing, and measure clinical outcome using established assessment tools and questionnaires. [ Time Frame: Assessed annually. ]Identify type of tick-borne disease and clinical outcome.
- Utilize current and future technologies to develop new direct and indirect tests and biomarkers for TBDs. These can include, but not limited to, antibody-based testing, antigen-based testing, molecular-based testing, culture. [ Time Frame: Ongoing ]Will use samples for developing novel diagnostic testing.
- Evaluation of the immune response to the pathogens. These can include, but are not limited to, cytokine testing, cellular response testing, antibody profile, metabolomics, proteomics, transcriptomics, and others. [ Time Frame: Ongoing ]Will use samples to explore human immune response to TBDs.
- Genomic-based testing for research on pathogen virulence and mutations. [ Time Frame: Ongoing ]Will use samples to explore pathogen.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318925
| Contact: Siu-Ping Turk, R.N. | (301) 451-7661 | sturk@cc.nih.gov |
| United States, Maryland | |
| University of Maryland Baltimore, Department of Medicine | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Kalpana Shere- Wolfe, MD 410-328-9102 kwolfe@umaryland.edu | |
| Principal Investigator: | Adriana R Marques, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT04318925 |
| Other Study ID Numbers: |
999920030 20-I-N030 |
| First Posted: | March 24, 2020 Key Record Dates |
| Last Update Posted: | June 16, 2021 |
| Last Verified: | June 10, 2021 |
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Lyme Borrelia Anaplasma Rickkettsia Lone Star |
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Lyme Disease Tick-Borne Diseases Borrelia Infections Gram-Negative Bacterial Infections Bacterial Infections |
Spirochaetales Infections Arbovirus Infections Virus Diseases Protozoan Infections Parasitic Diseases |