Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04318925
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2020-03-21
Brief Title:
Evaluation and Follow-up of People With Tick-borne Diseases
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Follow-up of Patients With Tick-borne Diseases
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 59000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-I-N030 | None | None | None |