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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318925
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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.


Condition or disease
Lyme Disease Tick-Borne Disease

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.

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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 : July 20, 2020
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : May 31, 2030

Resource links provided by the National Library of Medicine


Group/Cohort
1
Persons with diagnosed or suspected tick-borne disease age >=18 years



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Genomic-based testing for research on pathogen virulence and mutations. [ Time Frame: Ongoing ]
    Will use samples to explore pathogen.



Information from the National Library of Medicine

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.


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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
Study Population
Primary clinical
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Siu-Ping Turk, R.N. (301) 451-7661 sturk@cc.nih.gov

Locations
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United States, Maryland
University of Maryland Baltimore, Department of Medicine
Baltimore, Maryland, United States, 21201
Contact: Kalpana Shere- Wolfe, MD    410-328-9102    kwolfe@umaryland.edu   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Adriana R Marques, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Publications:
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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: July 15, 2020
Last Verified: April 16, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Lyme
Borrelia
Anaplasma
Rickkettsia
Lone Star
Additional relevant MeSH terms:
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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