Xenodiagnosis After Antibiotic Treatment for Lyme Disease

Completed · Not applicable

Conditions studied: Lyme Disease

In brief

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.

Key facts

Study ID

NCT02446626

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

72

Starts

2015-07-24

Expected to finish

2022-05-04

Last updated by the study team

2024-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• Oral or IV steroids in the previous 2 weeks (topical, nasal, inhaled, intra-articular, and replacement doses of steroids are not exclusions).
• Any other condition 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.
• Refusal to participate in specimen collection and storage for future study related use.
• EXCLUSION FROM SKIN BIOPSY PART OF THE PROTOCOL
• History of forming large thick scars (keloids) after skin injuries or surgery.
• History of excessive bleeding after cuts or procedures.
• Currently taking anticoagulants.
• History of allergy to lidocaine.

Where it is running

• Mansfield Family Practice — Storrs, Connecticut, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Stony Brook University (State University of New York) — Stony Brook, New York, United States
• New York Medical College — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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