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NCT02446626 · ClinicalTrials.gov registry record · NA
Xenodiagnosis After Antibiotic Treatment for Lyme Disease
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT02446626 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 72 participants.
The verdict
NCT02446626, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study Summary
Background: The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases of Lyme disease are cured by antibiotics, but some patients continue to experience symptoms despite the absence of detectable Lyme bacteria. Xenodiagnosis uses a vector to detect the presence of a disease-causing microbe. Researchers will use live, laboratory-bred ticks to see if Lyme disease bacteria can be detected in people after completing antibiotic therapy and if that is more common in people who continue to experience symptoms such as fatigue and joint pain. Objectives: \- To see if ticks can be used to detect B. burgdorferi in people who have had Lyme disease and received antibiotic therapy and if it correlates with persistent symptoms. Eligibility: * Adults at least 18 years old who have: * Untreated erythema migrans (the Lyme disease rash); OR * Untreated Lyme arthritis; OR * Continuing symptoms after treatment for Lyme disease; OR * Had Lyme disease and antibiotic treatment within the past 12 months. * Healthy volunteers Design: * Participants will be screened with medical history, physical exam, and blood tests. * Visit 1: * Blood and urine tests, health questionnaire. * Up to 30 laboratory-bred, pathogen-free, larval ticks (each smaller than a poppy seed) will be placed under a dressing. * Participants may have two small biopsies of skin . * 4 6 days later, Visit 2: * Dressing will be removed and ticks will be collected. * Participants will answer symptom questions. * If many ticks are still attached, participants will have to come back the next day. If not enough ticks feed successfully, the procedure may be repeated. * Participants will keep a diary of symptoms for 30 days. Over 3 months, they will be return to the clinic 3 times to see how they feel and answer questionnaires. Test results will be discussed.
Interventions
- PROCEDURE Blood draw
- PROCEDURE Skin biopsy
- DEVICE Xenodiagnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-07-24 |
| Est. Completion | 2022-05-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02446626
The ClinicalTrials.gov registry entry for NCT02446626 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Blood draw is the first listed.
NCT02446626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02446626 about?
NCT02446626 is a clinical study titled "Xenodiagnosis After Antibiotic Treatment for Lyme Disease". Background: The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases of Lyme disease are cured by antibiotics, but some patients continue to experience symptoms despite the ...
What is the current status of trial NCT02446626?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2015-07-24. Estimated completion is 2022-05-04.
What interventions are being tested in trial NCT02446626?
The interventions under investigation include: Blood draw (PROCEDURE), Skin biopsy (PROCEDURE), Xenodiagnosis (DEVICE).
Who is sponsoring clinical trial NCT02446626?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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