Clinical Research Directory

Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis

Study Objective: Neurosyphilis remains a major clinical challenge: despite standard first-line therapy with intravenous penicillin G, as recommended by international and Chinese guidelines, approximately 30% of patients have residual neurological impairment. Minocycline, a tetracycline antibiotic, has both anti-Treponema pallidum activity and independent anti-inflammatory and neuroprotective effects. We therefore designed a prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate whether the addition of minocycline to penicillin, as compared with penicillin monotherapy, improves the 6-month rate of favorable neurological outcomes in patients with neurosyphilis. This trial will provide evidence-based evidence for the treatment of neurosyphilis. Inclusion Criteria: 1）Age 18-80 years; 2）Diagnosis of neurosyphilis according to the Guidelines for the Diagnosis and Treatment of Syphilis, Gonorrhea and Genital Chlamydia trachomatis Infection (2020); 3）Cognitive impairment (MMSE score 10-26) or ischemic stroke-like episodes (time from onset to randomization ≤14 days, NIHSS score 1-20); 4）Written informed consent provided by the patient or their legally authorized representative. Intervention: Participants will be randomly assigned ( by chance ) to one of two groups. Group 1 will receive standard intravenous penicillin therapy plus oral minocycline for 28 days. Group 2 will receive standard intravenous penicillin therapy plus oral placebo for 28 days. All participants will receive standard penicillin treatment. Participants and their doctors will not know which group they are in. Follow-up: Participants will be followed for up to 12 months, with five follow-up visits: baseline (before treatment initiation), end of intravenous penicillin treatment (Day 12 ± 2 days), end of minocycline treatment (Day 28 + 2 days), 6 months post-treatment (Month 6 ± 7 days), and 12 months post-treatment (Month 12 ± 7 days). Assessments will include standardized neurological function scales for favorable neurological outcomes, cognitive function, neurological deficits, and activities of daily living; cerebrospinal fluid and serum efficacy marker testing; and brain MRI. Potential Benefits and Risks: Participants may or may not benefit from participating in this study. All participants will receive standard treatment for neurosyphilis. The main risks are complications that may occur during study procedures (such as lumbar puncture, or allergic reactions to penicillin) and possible side effects of minocycline, including dizziness, vestibular side effects, nausea, or skin sensitivity to sunlight. The study team will closely monitor participants for any adverse reactions. Importance of This Study: If minocycline does help improve neurological outcomes, it could become a new treatment option for patients with neurosyphilis, thereby helping to reduce the occurrence of neurological sequelae. The implementation of this study will provide evidence-based evidence for the treatment of neurosyphilis.

Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis

The goal of this observational study is to identify diagnostic biomarkers for neurosyphilis in patients with the condition. The main questions it aims to answer are: What plasma biomarkers are associated with neurosyphilis? What electrophysiological characteristics (EEG and eye movement) are linked to neurosyphilis? Researchers will compare biomarker data from plasma and gut microbiome analyses with electrophysiological findings to see if these factors can help diagnose neurosyphilis. Participants will: Provide clinical information such as age, gender, symptoms, and disease course Submit blood and urine samples for proteomics and metagenomic sequencing Undergo EEG and eye movement evaluations for electrophysiological analysis

Central Nervous System Infections in Denmark

The Danish Study Group of Infections of the Brain is a collaboration between all departments of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in central nervous system (CNS) infections by a prospective registration of clinical characteristics and outcome of all adult (\>17 years of age) patients with community-acquired CNS infections diagnosed and/or treated at departments of infectious diseases in Denmark since 1st of January 2015.