Clinical trial NCT04318925: Evaluation and Follow-up of People With Tick-borne Diseases
Official title: Evaluation and Follow-up of Patients With Tick-borne Diseases
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lyme Disease
Tick-Borne Disease
Keywords: Lyme
Borrelia
Anaplasma
Rickkettsia
Lone Star
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary clinical

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Assessed annually.
Secondary outcomes:
measure: 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.
timeFrame: Ongoing
measure: 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.
timeFrame: Ongoing
measure: Genomic-based testing for research on pathogen virulence and mutations.
timeFrame: Ongoing
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore, Department of Medicine
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Adriana R Marques, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.