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NCT00001539 · ClinicalTrials.gov registry record
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
A clinical trial of Lyme Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT00001539: Recruiting study of Lyme Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001539 is a study of Lyme Disease that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 700 participants, below the 3,797-participant average among 9 other Lyme Disease trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001539, a study of Lyme Disease, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials. Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme disease but do not have disease symptoms); recovered control (have been sick with Lyme disease but were treated successfully and are currently well); control with multiple sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic Lyme disease category must be age 13 and above; all others must be age18 and above. Candidates will be screened with blood and urine tests. Participants will have a physical examination and the following tests: Blood tests Includes HLA-typing, a genetic test of immune system markers; Leukapheresis Collection of large numbers of white blood cells Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle in the other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.); Lumbar puncture (spinal tap) Collection of cerebrospinal fluid (CSF, fluid that bathes the brain and spinal cord). A local anesthetic is administered and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle; Magnetic resonance imaging (MRI) of the brain Imaging of the brain
Primary Outcome
This protocol serves as the basis for multiple parallel lines of investigation in different aspects of Lyme disease and PTLDS. The formation of the cohort and follow up are the main outcomes.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 1996-06-13 |
What NCT00001539 shows while recruiting
NCT00001539 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 3,797-participant average among 9 other Lyme Disease trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Lyme Disease appearing as the primary indexed condition, and to 0 interventions.
NCT00001539 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001539 about?
NCT00001539 is a clinical study titled "A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations". This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringe...
What is the current status of trial NCT00001539?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 1996-06-13.
What conditions does trial NCT00001539 study?
This clinical trial studies the following conditions: Lyme Disease.
Who is sponsoring clinical trial NCT00001539?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001539 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lyme Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001539's enrollment target sits among peer trials
700 4th of 9 higher than 6 of 9 other Lyme Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lyme Disease 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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