Clinical Trial: Searching for Persistence of Infection in Lyme Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Searching for Persistence of Infection in Lyme Disease
Brief 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:
- Individuals at least 18 years of age who are in one of the following categories:
- Have had the erythema migrans rash (a symptom of Lyme infection) an
Detailed Summary:
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.
In this proposal, the utility of xenodiagnosis for identifying persistence of B. burgdorferi in treated human Lyme disease will be tested in up to 120 subjects with various stages of Lyme disease with 30 healthy adults to serve as controls. Subjects will be followed for approximately 3 months. In Objective #1, subjects who have the characteristic erythema migrans (EM) rash and have been treated with antibiotics early (within 3 weeks of infection) in the course of Lyme disease will be tested. After completion of antibiotic therapy, 25-30 larval Ixodes ticks will be allowed to feed on the subject and biopsies of the EM site will be performed. Repleted ticks will be collected and tested for the presence of B. burgdorferi. In Objective #2, similar studies will be performed, but enrollment will target subjects with elevated C6 (region 6 of the VlsE surface protein of B. burgdorferi) antibody levels. In Objective #3, patients with persistent symptoms after antibiotic therapy will be evaluated. As an attempt to increase the chances of a positive xenodiagnosis in humans, pati
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Determine whether xenodiagnosis can detect the continued presence of B. burgdorferi in patients with Lyme disease after antibiotic therapy. [ Time Frame: 5 years from first patient enrollment ]
Original Primary Outcome:
Current Secondary Outcome: Assess the safety of the planned xenodiagnostic procedure in humans. [ Time Frame: 5 years from first patient enrollment ]
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: June 11, 2010
Date Started: May 27, 2010
Date Completion:
Last Updated: May 12, 2017
Last Verified: November 25, 2016
