Clinical Trial: Xenodiagnosis After Antibiotic Treatment for Lyme Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Xenodiagnosis After Antibiotic Treatment for Lyme Disease - Phase II Study

Brief 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.

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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:
  • Lyme disease is the most common vector borne disease in the United States. Although antibiotic therapy is clinically effective in treating the symptoms of Lyme disease for most patients early in the course of disease, a significant number of patients who receive therapy report persistent symptoms. The cause of persistent symptoms after antibiotic therapy for Lyme disease is an area of great controversy. Recent studies have shown that the organism (Borrelia burgdorferi) may persist in animals after antibiotic therapy and can be detected by using the natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). Whether this occurs in humans is unknown. Currently available tests for human Lyme disease do not allow determination of persistent infection after antibiotic therapy.

    We performed the first study of the use of I. scapularis larva for the xenodiagnosis of B. burgdorferi infection in humans. Our pilot study showed that xenodiagnosis was well tolerated with no severe adverse events (AEs). The most common AE was mild itching at the site. In this small pilot study, xenodiagnosis for B. burgdorferi was positive in 2 participants and indeterminate in 2 participants. Further studies are needed to determine the sensitivity of xenodiagnosis in evaluating the infection status of Lyme disease patients.

    In this proposal, we want to further investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease. Our objectives include assessing the link between detection of B. burgdorferi by xenodiagnosis and persistence of symptoms in patients diagnosed with Lyme disease, within 1 year, post therapy; compare the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms; i
    Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

    Current Primary Outcome:

    • This study is powered to detect difference in the positivity rate between symptomatic and asymptomatic individuals. [ Time Frame: 4-6 weeks post tick removal visit, and approximately 3 months post tick removal visit. ]
    • The study will continue to assess the safety of xenodiagnosis in humans. [ Time Frame: Throughout the study ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: May 13, 2015
    Date Started: May 1, 2015
    Date Completion: December 1, 2030
    Last Updated: May 12, 2017
    Last Verified: December 6, 2016