Xenodiagnosis After Antibiotic Treatment for Lyme Disease (NCT02446626) | Clinical Trial Compass
CompletedNot Applicable
Xenodiagnosis After Antibiotic Treatment for Lyme Disease
United States72 participantsStarted 2015-07-24
Plain-language summary
Background:
The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases of Lyme disease are cured by antibiotics, but some patients continue to experience symptoms despite the absence of detectable Lyme bacteria. Xenodiagnosis uses a vector to detect the presence of a disease-causing microbe. Researchers will use live, laboratory-bred ticks to see if Lyme disease bacteria can be detected in people after completing antibiotic therapy and if that is more common in people who continue to experience symptoms such as fatigue and joint pain.
Objectives:
\- To see if ticks can be used to detect B. burgdorferi in people who have had Lyme disease and received antibiotic therapy and if it correlates with persistent symptoms.
Eligibility:
* Adults at least 18 years old who have:
* Untreated erythema migrans (the Lyme disease rash); OR
* Untreated Lyme arthritis; OR
* Continuing symptoms after treatment for Lyme disease; OR
* Had Lyme disease and antibiotic treatment within the past 12 months.
* Healthy volunteers
Design:
* Participants will be screened with medical history, physical exam, and blood tests.
* Visit 1:
* Blood and urine tests, health questionnaire.
* Up to 30 laboratory-bred, pathogen-free, larval ticks (each smaller than a poppy seed) will be placed under a dressing.
* Participants may have two small biopsies of skin .
* 4 6 days later, Visit 2:
* Dressing will be removed and ticks will be collected.
* Participants will answer symptom questions.
* If many ticks are still attached, participants will have to come back the next day. If not enough ticks feed successfully, the procedure may be repeated.
* Participants will keep a diary of symptoms for 30 days. Over 3 months, they will be return to the clinic 3 times to see how they feel and answer questionnaires. Test results will be discussed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 or older
. Lyme disease diagnosed in the previous 13 months, fulfilling the case definition of confirmed or probable Lyme disease by the US Centers for Disease Control and Prevention (CDC) (https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/).
. Completion of 1 course of antibiotics at least 3 months and up to 12 months between the end of the therapy and the xenodiagnostic procedure.
. Antibiotic treatment fulfills the Infectious Diseases Society of America guidelines for the recommended therapy for Lyme disease
. Age 18 or older.
. Diagnosed with confirmed or probable Lyme disease fulfilling the case definition of Lyme disease by the CDC (https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection of Borrelia Burgdorferi in Ticks After Xenodiagnosis Procedure
Timeframe: 3-6 days post tick placement
2
Participants With Adverse Event Related to the Application of Ticks (Xenodiagnosis)
Timeframe: Up to 30-days after tick removal
Trial details
NCT IDNCT02446626
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Received recommended antibiotic therapy for Lyme disease 5 at least 12 months between the end of the initial antibiotic therapy and the xenodiagnostic procedure.
. Persistent or recurrent symptoms that began or worsened within 6 months of the diagnosis and treatment for Lyme disease.
Exclusion criteria
. No antibiotic therapy active against Lyme disease in the previous 3 months (except patients with acute EM). Prophylaxis with a single dose of doxycycline 200 mg is not an exclusion.
. History of allergy to surgical tape or dressing.
. History of severe reactions to tick bites (granuloma or systemic reactions).
. Inability to maintain the dressing for any reason.
. Pregnancy or lactation.
. Unwillingness to use an effective method of birth control for the duration of participation in the study (women of child-bearing potential only) and for at least 3 months following the last tick placement.
. Use of investigational therapy and devices during the time of the study and/or in the month prior to signing the informed consent.
. Active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin cancers, autoimmune disease requiring immunosuppressive therapy, or history of HIV, chronic viral hepatitis, or syphilis.