Lyme DiseaseNCT04318925
Evaluation and Follow-up of People With Tick-borne Diseases
An observational study of Lyme Disease and Tick-Borne Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Disease, Tick-Borne Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 13 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary clinical
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore, Department of Medicine
Baltimore, Maryland, 21201
About this study
Official title: Evaluation and Follow-up of Patients With Tick-borne Diseases
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.
Read more
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.
Read the 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.
- Conditions
- Lyme Disease, Tick-Borne Disease
- Keywords
- Lyme, Borrelia, Anaplasma, Rickkettsia, Lone Star, Natural History
- Medical subject headings
- Lyme Disease, Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Persons with diagnosed or suspected tick-borne disease age >=18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Will use samples for developing novel diagnostic testing.
Measured: 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.
Will use samples to explore human immune response to TBDs.
Measured: Ongoing
Genomic-based testing for research on pathogen virulence and mutations.
Will use samples to explore pathogen.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start13 Nov 2023
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Adriana R Marques, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318925
- Sponsor's protocol ID
- 999920030
- Other IDs
- 20-I-N030
- Status last verified
- Nov 2023
- First submitted
- 21 Mar 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27151067Coipan 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.
PubMed 27125686Marques 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.
PubMed 29898997
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Follow-up of Patients With Tick-borne Diseases
- ClinicalTrials.gov ID
- NCT04318925
- Acronym / sponsor ID
- 999920030
- Conditions
- Lyme Disease, Tick-Borne Disease
- Keywords
- Lyme, Borrelia, Anaplasma, Rickkettsia, Lone Star, Natural History
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Persons with diagnosed or suspected tick-borne disease age >=18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
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
Genomic-based testing for research on pathogen virulence and mutations.
Time frame: Ongoing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 27151067Nelder 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.
- Background: PubMed 27125686Coipan 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.
- Background: PubMed 29898997Marques 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.
Related trials for Lyme Disease
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana R Marques, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease and Tick-Borne Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Assessed annually.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318925, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.