- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318925
Evaluation and Follow-up of People With Tick-borne Diseases
Evaluation and Follow-up of Patients With Tick-borne Diseases
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Contacts and Locations
Study Contact
- Name: Siu-Ping Turk, R.N.
- Phone Number: (301) 451-7661
- Email: sturk1@mail.nih.gov
Study Contact Backup
- Name: Adriana R Marques, M.D.
- Phone Number: (301) 435-7244
- Email: amarques@niaid.nih.gov
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Baltimore, Department of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Persons with diagnosed or suspected tick-borne disease age >=18 years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Identify type of tick-borne disease and clinical outcome.
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Assessed annually.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Will use samples for developing novel diagnostic testing.
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Ongoing
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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
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Will use samples to explore human immune response to TBDs.
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Ongoing
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Genomic-based testing for research on pathogen virulence and mutations.
Time Frame: Ongoing
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Will use samples to explore pathogen.
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Ongoing
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Collaborators and Investigators
Investigators
- Principal Investigator: Adriana R Marques, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Publications and helpful links
General Publications
- Nelder MP, Russell CB, Sheehan NJ, Sander B, Moore S, Li Y, Johnson S, Patel SN, Sider D. Human pathogens associated with the blacklegged tick Ixodes scapularis: a systematic review. Parasit Vectors. 2016 May 5;9:265. doi: 10.1186/s13071-016-1529-y.
- Coipan EC, Jahfari S, Fonville M, Oei GA, Spanjaard L, Takumi K, Hovius JW, Sprong H. Imbalanced presence of Borrelia burgdorferi s.l. multilocus sequence types in clinical manifestations of Lyme borreliosis. Infect Genet Evol. 2016 Aug;42:66-76. doi: 10.1016/j.meegid.2016.04.019. Epub 2016 Apr 25.
- Marques AR. Revisiting the Lyme Disease Serodiagnostic Algorithm: the Momentum Gathers. J Clin Microbiol. 2018 Jul 26;56(8):e00749-18. doi: 10.1128/JCM.00749-18. Print 2018 Aug.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999920030
- 20-I-N030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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