NCT01143558

Searching for Persistence of Infection in Lyme Disease

Completed EARLY_PHASE1 Last updated 14 April 2026

What this trial tests

EARLY_PHASE1 trial testing Lyme Disease Xenodiagnosis in Lyme Disease in 45 participants. Completed in 30 December 2014.

Timeline

4 November 2010

Primary endpoint
30 December 2014

30 December 2014

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	45
Start date	4 November 2010
Primary completion	30 December 2014
Estimated completion	30 December 2014
Sites	3 locations across United States

Drugs / interventions tested

• Lyme Disease Xenodiagnosis

Conditions studied

• Lyme Disease — all drugs for Lyme Disease →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with Lyme Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Xenodiagnosis to detect Borrelia burgdorferi infection: a first-in-human study.
   Marques A, Telford SR, Turk SP, Chung E, et al · · 2014 · cited 93× · PMID 24523212 · DOI 10.1093/cid/cit939