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NCT01143558 · ClinicalTrials.gov registry record · Early Phase 1
Searching for Persistence of Infection in Lyme Disease
A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
NCT01143558: Completed Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01143558 is a Early Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143558, a Early Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 45 participants
- Enrollment target
Study 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
Primary Outcome
AE reporting per protocol toxicity table
Interventions
- DEVICE Lyme Disease Xenodiagnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-11-04 |
| Est. Completion | 2014-12-30 |
| Phase | Early Phase 1 |
What the finished NCT01143558 record still lists
NCT01143558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which Lyme Disease Xenodiagnosis is the first listed.
NCT01143558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01143558 about?
NCT01143558 is a clinical study titled "Searching for Persistence of Infection in Lyme Disease". 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 ta...
What is the current status of trial NCT01143558?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2010-11-04. Estimated completion is 2014-12-30.
What interventions are being tested in trial NCT01143558?
The interventions under investigation include: Lyme Disease Xenodiagnosis (DEVICE).
Who is sponsoring clinical trial NCT01143558?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01143558's enrollment target sits among peer trials
45 575th of 2000 higher than 1,412 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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