Searching for Persistence of Infection in Lyme Disease

Summary

Background:

Lyme disease is an infection caused by Borrelia burgdorferi, a bacteria that is transmitted to humans by ticks. It can cause many different symptoms including rash, fever, headache, meningitis (infection of the central nervous system), and arthritis. While most patients improve after taking antibiotics, some patients continue to have symptoms. It is currently unknown why some patients continue to have symptoms. One possibility is that the antibiotics have not successfully gotten rid of all of the bacteria. Current tests for Lyme disease cannot tell whether the bacteria have been successfully eliminated from the body.

Xenodiagnosis is a way to look for Borrelia bacteria using the animal that usually hosts them, Ixodes scapularis (also known as the deer tick). This method takes advantage of the evolution of the bacteria and the insect that transmits the infection, which can make the insect particularly good at finding the agent. In studies of animals, xenodiagnosis may be more sensitive than current tests for detecting the presence of the Lyme disease bacteria. Researchers are interested in using xenodiagnosis to determine whether uninfected ticks that feed on humans who have been infected with Lyme disease bacteria can detect the continued presence of live bacteria.

Objectives:

\- To determine whether xenodiagnosis can be used to successfully investigate the presence of Lyme disease bacteria.

Eligibility:

1. Individuals at least 18 years of age who are in one of the following categories:
2. Have had the erythema migrans rash (a symptom of Lyme infection) and received antibiotic therapy less than 4 months ago (but have not had antibiotics in the previous month).
3. Have the erythema migrans rash and received less than 2 days of antibiotic therapy.
4. Have been diagnosed with early or late Lyme disease, have received antibiotic therapy, but still have high levels of antibodies against the bacteria at least 6 months after therapy, and have not received antibiotics in the past 3 months.
5. Have been diagnosed with early or late Lyme disease, have received antibiotic therapy, and have new complaints of fatigue or other symptoms that are persistent for at least 6 months after completion of antibiotic therapy, and have not received antibiotics in the past 3 months.
6. Have been diagnosed with Lyme arthritis and have not yet received antibiotic therapy.
7. Healthy volunteers who have not had Lyme disease will also be included in this study.

Design:

* Participants will have an initial visit for a physical examination, medical history, and blood sample.
* For the first study visit, researchers will place a strip of filter paper or a small plastic container with 20 to 30 disease-free ticks on the participant s skin. If possible, the ticks will be placed at the site of a Lyme disease rash or another suspicious area, or on the nondominant forearm. Participants will be asked to keep the ticks in place, and will keep a diary card at home to record any symptoms or problems.
* The ticks will be collected 4 to 6 days after placement. At that visit, participants will have a skin biopsy taken of the area tested, a blood sample will be collected, and participants will receive a new diary card to keep until the next clinic visit.
* After 1 month, participants will provide a final blood sample, and will receive a follow-up phone call 2 months afterward.

Conditions

• Lyme Disease

Interventions

DEVICE

Lyme Disease Xenodiagnosis

Clean laboratory-bred ticks are the FDA registered IDE. These ticks are placed on patients to search for evidence of Borrelia burgdorferi.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Adriana R Marques, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-04

Primary Completion

2014-12-30

Completion

2014-12-30

FDA Device

Yes

Countries

• United States

Study Locations