Lyme Disease

Researchers are evaluating the use of 64Cu-DOTATATE PETCTMRI imaging to improve diagnosis and monitoring of Lyme neuroborreliosis LNB, a tick-borne infection affecting the nervous system. This study aims to compare patients clinically suspected and cerebrospinal fluid CSF verified with LNB against those suspected without CSF verification. The goal is to see if this imaging technique can provide more precise diagnosis, prognostic information, and risk assessment for lingering symptoms after treatment. The study involves 50 patients divided into two groups 25 with possible or confirmed neuroborreliosis and 25 investigated but with normal CSF results. Participants will undergo 64Cu-DOTATATE PETCTMRI scans, which target activated macrophages involved in infection. This non-invasive imaging method is being assessed for its diagnostic value and ability to support follow-up six months after treatment, alongside blood biomarker testing including sCD163, NfL, and Tau. During the study, participants will have PETCTMRI scans to measure tracer uptake in the central nervous system and reference organs. Clinical symptoms, laboratory markers, and imaging results will be tracked to evaluate disease activity and prognosis. The primary outcomes focus on diagnostic performance over 2.5 years, with secondary measures also assessed. The study monitors patients without interventions beyond imaging and biomarker collection, lasting from initial evaluation through follow-up visits.

Researchers are investigating whether the Lyme disease bacteria, Borrelia burgdorferi, remain alive in patients after antibiotic treatment and whether this persistence causes ongoing symptoms. The study aims to better define diagnostic criteria for Lyme disease and support the development of future treatment trials by following a well-characterized group of patients with post-treatment Lyme disease syndrome PTLDS and various control groups. Participants include those with chronic Lyme disease, Lyme arthritis, multiple sclerosis, previous Lyme infection with full recovery, seropositive individuals without symptoms, and healthy volunteers. Participants undergo physical exams and tests including blood tests, white blood cell collection or blood draw, lumbar puncture, brain MRI, neuropsychological assessments, and sometimes hearing tests and urine collection. Those testing positive for the bacteria are monitored every 3 to 6 months and may receive antibiotic treatment with ceftriaxone, followed by scheduled follow-ups with repeated tests and imaging to evaluate treatment response. Throughout the study, participants are regularly assessed with clinical exams, imaging, laboratory tests, and questionnaires to understand disease progression and immune response. The research team collects data on biological markers, develops new diagnostic tests, and monitors symptoms and treatment outcomes over time. Participants may be reevaluated at intervals of 6 to 12 months, contributing to a detailed database to guide future Lyme disease research and therapies.

This research investigates cases of disseminated borreliosis, an infection caused by Borrelia burgdorferi sl. and Borrelia miyamotoi, in patients who have received treatment with anti-CD20 monoclonal antibodies. The study aims to clinically, biologically, radiologically, and pharmacologically describe these cases to better understand the infection among this specific patient group in France. The study is observational and collects data from patients who developed disseminated borreliosis within 24 months after receiving anti-CD20 therapy between January 2010 and July 2025. It does not involve administering treatments but focuses on monitoring and describing the diseases presentation and course. Participants will be evaluated for up to 12 months, during which researchers will document the clinical presentation of borreliosis cases. The study involves collecting medical information and biological data to characterize the infection. There is no intervention, and participants usual medical care continues throughout the observation period.

Researchers are studying the safety and immune response of a fifth dose of the Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older who have already received four doses of this vaccine. This Phase 3 trial compares the effects of the vaccine against a placebo saline to better understand its protection against Lyme disease. The study is randomized, placebo-controlled, and double-blinded, aiming to assess tolerability and immune response. Participants receive one injection, either VLA15 or saline, into the muscle of the upper arm at their first visit. They are randomized in a 51 ratio to either vaccine or placebo. The timing of the fifth dose varies, occurring either one or two years after the fourth dose from a previous study. The trial includes about 1712 participants and uses an independent data monitoring committee to oversee safety. During approximately 12 months of participation, individuals will attend four clinic visits. These visits include health checks, blood draws to measure immune response, and receiving the study injection during the first visit. Researchers will monitor local and systemic reactions within seven days post-injection, adverse events up to one month, and longer-term safety for up to a year. The main outcomes focus on immune responses to different parts of the vaccine and recording any side effects or new medical conditions.

Researchers are evaluating new home-based methods to measure medication and chemical concentrations in sweat and saliva compared to standard blood tests in patients with chronic or infectious diseases who are receiving medications. The study aims to see if a smart wristband can accurately monitor substances like electrolytes and metabolites in sweat, which may help in health monitoring and disease diagnosis. This pilot observational study is focused on assessing the feasibility of these wearable sweat sensors. Participants provide sweat samples using a Macroduct Sweat Collection System, saliva samples, and blood samples within 24 hours after taking their medications. They also complete short questionnaires lasting 5 to 10 minutes and allow their medical records to be reviewed. The study collects samples and data to compare the new home-based methods against the standard liquid chromatography-mass spectrometry of plasma. During the study, patients are followed periodically after completing sample collection to monitor results and assess feasibility. Researchers measure how well the home-based sampling predicts medication levels and observe plasma concentrations within 4 hours. The study includes ongoing follow-up to evaluate the ease of obtaining home-based samples and to review medical data over time.

Researchers are conducting an observational study called the BRILLIANT study to better understand Lyme disease LD in children aged 0 to 17 years. This study aims to develop a new diagnostic test for early LD by measuring Borrelia burgdorferi-specific antibody-secreting cells ASCs and to analyze the immune response in children with LD. The study also seeks to identify different strains of the bacteria causing LD and gather clinical data on symptoms, disease severity, treatment, and outcomes. The study involves two groups children suspected of having LD presenting in the emergency department, and previously healthy children undergoing routine blood tests as controls. Participants will provide venous blood samples at their first hospital visit and during follow-up visits at 28 days, 3 months, and 6 months. Additional samples of cerebrospinal fluid or joint fluid may be collected if medically needed. Researchers will use various laboratory techniques such as ELISpot, flow cytometry, and genome sequencing to study the immune response and bacterial types. Participants will have clinical and laboratory data collected at multiple visits, including symptoms, routine tests, and treatment information. The study will monitor immune cells, antibody levels, and bacterial presence over time. The primary outcome is the number of Borrelia-specific ASCs in blood, measured between October 2023 and October 2026. Secondary outcomes include immune cell measurements, antibody levels, T cell counts, cytokine levels, and bacterial typing through October 2028. The total participation lasts up to six months with scheduled follow-ups for thorough monitoring.

Researchers are evaluating whether an FDA-approved drug called Ceftriaxone, given intermittently, can help adults aged 18 to 75 who have a history of Lyme disease and continue to experience persistent or returning symptoms after completing treatment. The study aims to determine if Ceftriaxone, given approximately every 5 days for 6 weeks, is safe and well tolerated compared to a placebo and whether it improves symptoms in these individuals. Participants will receive intravenous infusions of either 2 grams of Ceftriaxone or a placebo of dextrose 5% in water, administered about every 5 days for a total of 9 treatments over 6 weeks. After treatment, participants will have follow-up visits one month after the last treatment and again at approximately 3 and 6 months from the start of the study. At 6 months, the study will be unblinded, and those who initially received placebo may repeat the treatment with Ceftriaxone. Participants originally treated with Ceftriaxone will receive a phone follow-up at one year. During the study, participants will attend clinic visits for infusions and complete questionnaires assessing fatigue, physical functioning, general health, anxiety, depression, sleep, and suicidal thoughts. Blood samples will be collected to monitor safety and understand how the drug affects Lyme disease symptoms. Researchers will measure laboratory abnormalities, adverse events, and symptom changes over one year to assess safety and treatment impact.

Researchers are conducting a nationwide observational study in Denmark to track and understand infections of the central nervous system CNS among adults aged 18 years and older. This study systematically registers clinical characteristics and outcomes of all community-acquired CNS infections diagnosed or treated at infectious disease departments across the country since January 1, 2015. The aim is to monitor trends in infections such as bacterial meningitis, viral meningitis, encephalitis, brain abscess, neuroborreliosis, and neurosyphilis, among others. The study involves collecting detailed information on diagnosis at admission, symptoms, timing and type of diagnostic tests like lumbar puncture and cranial imaging, and treatments given. These treatments and diagnostic procedures are determined by local physicians and are not standardized across sites. The study ensures data quality through regular case reviews and annual checks of hospital records using specific diagnosis codes to identify CNS infection cases. Participants are monitored for outcomes using the Glasgow Outcome Scale at various time points depending on the infection type, such as 2 weeks for neurosyphilis and 8 weeks for brain abscess. Data on timing of hospital admission, diagnostic procedures, and antibiotic treatment are collected from hospital records. The studys main measure is the yearly incidence of CNS infections, capturing clinical course and patient outcomes to improve understanding of these serious infections over time.

Researchers are comparing different treatment plans using amoxicillin in patients diagnosed with erythema migrans. The study aims to assess how effective these treatments are in managing symptoms and signs related to Lyme borreliosis. It is a Phase 3 clinical trial sponsored by the University Medical Centre Ljubljana to better understand treatment duration and dosage effects. Participants will be randomly assigned to one of three groups one receiving amoxicillin 500 mg three times a day for 10 days, another receiving the same dose for 14 days, and a control group without Lyme borreliosis receiving no intervention. This design allows comparison of two active treatment durations against a control group. During the study, researchers will monitor patients for one year to observe the occurrence of objective signs or subjective symptoms of Lyme borreliosis after treatment. They will also track nonspecific symptoms. The trial involves regular follow-ups to evaluate these outcomes and assess overall patient health related to the condition and treatments.

Researchers are evaluating the effectiveness of two different treatment durations of doxycycline in patients diagnosed with multiple erythema migrans, a condition related to Lyme borreliosis. The study compares a 7-day course versus a 14-day course of doxycycline to see which treatment better prevents symptoms and clinical signs associated with Lyme borreliosis over time. Participants are randomly assigned to one of three groups receiving doxycycline for 7 days, doxycycline for 14 days, or a control group without a history of Lyme disease that receives no intervention. The doxycycline is administered as 100 milligram oral tablets taken twice daily. This randomized clinical trial does not use blinding. Throughout the study, participants will be monitored at multiple time points 14 days, 2 months, 6 months, and 12 months after enrollment. Researchers will check for the presence of Lyme borreliosis symptoms and post-Lyme symptoms using objective clinical measurements. They will also assess changes in nonspecific symptoms at enrollment, 6 months, and 12 months. This follow-up allows detailed observation of treatment outcomes and symptom progression.