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Lyme Disease - ClinicalTrials.gov

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Last Updated: 15 November 2022

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Searching for Persistence of Infection in Lyme Disease

Lyme disease is the most common vector-borne disease in the United States. Although antibiotic therapy is proving to be safe in treating Lyme disease in the early stages of disease for the majority of patients early in the disease course, a substantial number of patients receiving therapy show persistent symptoms. Chronic symptoms following antibiotic therapy for Lyme disease is a point of considerable debate. Currently available human Lyme disease tests don't reveal persistent infection after antibiotic therapy. B. burgdorferi in treated human Lyme disease patients will be tested in up to 120 patients with various stages of Lyme disease in this study, with 30 healthy adults serving as controls. Objective #1: Subjects with the characteristic erythema migrant rash and antibiotic therapy early in the course of Lyme disease will be tested. Completed ticks will be collected and tested for B. burgdorferi. Patients with persistent symptoms after antibiotic therapy will be evaluated in Objective #3. Patients with accelerated xenodiagnosis in humans, patients with EM, patients with a negative xenodiagnosis in humans, patients with EM who are in the first two days of antibiotic therapy, and patients with untreated Lyme arthritis will all be evaluated. B. burgdorferi can be recovered by xenodiagnosis after antibiotic therapy in patients with continuing symptoms of disease can alter the current disease model and give researchers and clinicians a tool for identifying patients with persistent infections.

Source link: https://clinicaltrials.gov/ct2/show/NCT01143558


Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

Lyme disease is a multisystem disease caused by the spirochete Borrelia burgdorferi, and it is the most common vector-borne disease in the United States. These research sub-projects focus on identifying Borrelia virus genetic signatures, analysis of clinical course and outcomes of patients with Lyme disease, and the immune response to B. burgdorferi infection.

Source link: https://clinicaltrials.gov/ct2/show/NCT00028080


T4 - Tetracycline Treatment Tolerability Trial A Pilot Study Examining the Feasibility and Tolerability of Tetracycline Therapy in Post-Treatment Lyme Disease (PTLD)

There is a precedent for the use of tetracycline class antibiotics as an anti-inflammatory agent in chronic illnesses, such as dermatologic and rheumatologic disorders. The 2015 American College of Rheumatoid Arthritis Treatment Guideline for the Treatment of Rheumatoid Arthritis includes long-term therapy with tetracycline in its treatment guidelines. This pilot study was designed to explore the risk and tolerability of tetracycline therapy in reducing PTLD symptoms in PTLD patients at the end of the three-month treatment period, but the investigators intend to review preliminary data on the tetracycline treatment in reducing PTLD symptoms in PTLD patients. Lastly, in the sequel period, the investigators will investigate the effects of 3 months of tetracycline in the placebo arm as an investigation.

Source link: https://clinicaltrials.gov/ct2/show/NCT05219929


A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

Lyme disease has emerged as the leading vector-borne disease in the United States. The aim of this research is to collect and analyze a large population of patients with post-treatment Lyme disease syndrome and related conditions that will produce a prospective database on which stringent diagnostic criteria can be established and future therapeutic trials can be performed.

Source link: https://clinicaltrials.gov/ct2/show/NCT00001539


A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age

The main aim of this clinical study is to determine whether a 6-valent OspA-based Lyme disease vaccine can be used to control Lyme disease in North America and Europe. Around 18,000 healthy participants 5 years and older will be recruited from areas with high incidences of endemic Lyme disease to be eligible for VLA15 or placebo. To determine lot equivalence, a subgroup of participants will be given VLA15 from 3 distinct lots or placebo. The primary series of vaccination of participants will be completed at a time of year where the primary series is completed before the peak Lyme disease season is complete and a booster dose is administered just before the second Lyme disease season begins. Those that receive the study vaccine will be compared to those who do not. Participants will have to visit the research site at least 7 times during the study if enrolled.

Source link: https://clinicaltrials.gov/ct2/show/NCT05477524

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions