Borrelia Infection (Lyme Disease)

Researchers are evaluating the use of 64Cu-DOTATATE PET/CT/MRI 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 PET/CT/MRI 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 PET/CT/MRI 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 patients infected with the Lyme disease bacteria, Borrelia burgdorferi, who have been treated with antibiotics still harbor live bacteria that cause ongoing symptoms. The study aims to help develop strict diagnostic criteria for Lyme disease and inform future treatment trials. It includes people with chronic Lyme disease, Lyme arthritis, seropositive controls without symptoms, recovered patients, multiple sclerosis patients, and healthy volunteers. Participants will undergo physical exams and various tests including blood tests for immune markers, leukapheresis to collect white blood cells or a smaller blood draw, lumbar puncture to collect spinal fluid, brain MRI scans, neuropsychological tests, hearing tests, and urine collection. Those testing positive for the bacteria will be followed regularly and offered antibiotic treatment with ceftriaxone. Follow-up visits will include repeat testing and imaging to monitor treatment response. Some participants may be reevaluated every 6 to 12 months. Throughout the study, participants will be monitored with blood and urine tests, lumbar punctures, hearing exams, MRI scans, and neuropsychological assessments. The research team will collect data to understand the biological markers and immune responses in post-treatment Lyme disease syndrome. The study is ongoing, with regular follow-ups to assess clinical outcomes, treatment effects, and to build a detailed patient database for future research.

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 disease's 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 evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating the safety, tolerability, and how the body processes TP05 when taken orally by healthy adults who are at high risk of tick exposure. This Phase 2b study is randomized, double-blind, and placebo-controlled, aiming to gather important safety and effectiveness data before potential Lyme Borreliosis exposure. The trial is sponsored by Tarsus Pharmaceuticals, Inc. and includes adults aged 18 to 70 years. Participants will be randomly assigned to receive either a high dose or low dose of TP05, or a matching placebo, following a set dosing schedule. The study includes a screening period, a treatment period lasting up to 24 weeks, and a safety follow-up period. The treatment is given orally as tablets, and participants will be monitored for about 15 months to check for tick bites or signs of Lyme borreliosis. During the trial, participants will undergo regular safety assessments including monitoring for adverse events, blood chemistry, blood counts, vital signs, physical exams, and heart monitoring via ECGs. Researchers will also measure drug levels and how the drug is cleared from the body. Follow-up visits will continue for an average of 15 months to ensure participant safety and evaluate any symptoms related to tick exposure.

Researchers are evaluating the safety, reactogenicity, and immune response of a new vaccine called mRNA-1982 designed to prevent Lyme disease in healthy adults aged 18 to 70 years. This Phase 2 clinical trial aims to find the best dose and assess how well the vaccine triggers the body's defenses against Lyme disease. Participants will receive either the mRNA-1982 vaccine or a placebo through an injection into the muscle. The study includes two main parts: a dose-finding phase where different doses are tested, and a booster phase where participants may receive a booster shot of the vaccine or placebo. Both phases monitor reactions shortly after the injections and track immune responses over several months. During the study, participants will undergo medical evaluations, including monitoring for any side effects or adverse events from the first day up to 21 months after injection. Researchers will measure immune responses by testing blood samples for specific antibodies at multiple time points during both phases. The total participation may last up to nearly two years to ensure thorough safety and immune response data collection.

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 5:1 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 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 study's main measure is the yearly incidence of CNS infections, capturing clinical course and patient outcomes to improve understanding of these serious infections over time.