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

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ClinicalTrials.gov Identifier: NCT04318925
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date March 21, 2020
First Posted Date March 24, 2020
Last Update Posted Date August 2, 2021
Estimated Study Start Date August 5, 2021
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 21, 2020)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation and Follow-up of People With Tick-borne Diseases
Official Title Evaluation and Follow-up of Patients With Tick-borne Diseases
Brief Summary

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.

Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary clinical
Condition
  • Lyme Disease
  • Tick-Borne Disease
Intervention Not Provided
Study Groups/Cohorts 1
Persons with diagnosed or suspected tick-borne disease age >=18 years
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 21, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2030
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Siu-Ping Turk, R.N. (301) 451-7661 sturk1@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04318925
Other Study ID Numbers 999920030
20-I-N030
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Principal Investigator: Adriana R Marques, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 10, 2021