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Clinical trialNCT02446626CompletedInterventional

Xenodiagnosis After Antibiotic Treatment for Lyme Disease

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment72Lyme Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Adriana R Marques, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
24 Jul 2015
Primary completion
4 May 2022
Completion
4 May 2022
Last update posted
3 Jun 2024
Registered enrollment
72
Registry id
NCT02446626

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.