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

NCT04318925 | Withdrawn

• 2 other identifiers: 99992003020-I-N030
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Disease; Tick-Borne Disease

Keywords

Lyme; Borrelia; Anaplasma; Rickkettsia; Lone Star; Natural History

Outcome Measures

Primary Outcomes (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.

  Identify type of tick-borne disease and clinical outcome.

  Assessed annually.

Secondary Outcomes (3)

• 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.

  Ongoing

• 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.

  Ongoing

• Genomic-based testing for research on pathogen virulence and mutations.

  Ongoing

Study Arms (1)

1

Persons with diagnosed or suspected tick-borne disease age \>=18 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary clinical

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Maryland Baltimore, Department of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

• 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.

  PMID: 27151067 BACKGROUND

• 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.

  PMID: 27125686 BACKGROUND

• 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.

  PMID: 29898997 BACKGROUND

MeSH Terms

Conditions

Lyme Disease; Tick-Borne Diseases

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Vector Borne Diseases

Study Officials

• Adriana R Marques, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 24, 2020
• Study Start: November 13, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)