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NCT07904533

PHASE3

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

Sponsor: Beijing Ditan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial （MIN-ADD）

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

778

Start Date

2026-11-15

Completion Date

2028-12-22

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Neurosyphilis

Interventions

DRUG

Minocycline

Administered orally. Loading dose of 200 mg on Day 1, followed by 100 mg every 12 hours for 28 days. Given only to participants in the Experimental Group.

DRUG

Minocycline placebo

Oral matching placebo to minocycline. Loading dose of 200 mg on Day 1, followed by 100 mg every 12 hours for 28 days. Given only to participants in the Control Group.

DRUG

Aqueous crystalline penicillin G

Administered intravenously at 18-24 million units per day for 10-14 days. Given to all participants in both arms.

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 10-26) or ischemic stroke-like episodes (time from onset to randomization ≤14 days, NIHSS 1-20); 4. Written informed consent provided by the patient or their legally authorized representative. Exclusion Criteria: 1. Allergy or resistance to penicillin or tetracycline antibiotics (including minocycline). 2. Intravenous or intramuscular ceftriaxone for neurosyphilis within 1 month before enrolment (a single intramuscular dose of ceftriaxone for another infection is not exclusionary). 3. Use of tetracycline antibiotics within 1 month before enrolment. 4. Systemic immunosuppression meeting any of the following criteria: use of systemic glucocorticoids (oral or intravenous) within 3 months before enrolment (prednisone-equivalent dose \>10 mg/day for \>2 weeks); current use of immunosuppressants (including but not limited to methotrexate, azathioprine, ciclosporin, mycophenolate mofetil, TNF-α inhibitors, or JAK inhibitors); or discontinuation of immunosuppressants within \<4 weeks or \<5 half-lives (whichever is longer). 5. Pre-morbid modified Rankin Scale (mRS) score \>2. 6. History of psychiatric disorders (e.g., schizophrenia or depression). 7. HIV infection meeting any of the following criteria: screening CD4+ T-cell count \<200 cells/μL; or virological failure, defined as receiving antiretroviral therapy for ≥6 months with two consecutive plasma HIV RNA levels \>200 copies/mL (measured 2-4 weeks apart). 8. Cognitive impairment from other causes (e.g., Alzheimer's disease, frontotemporal dementia, thyroid dysfunction, folate/vitamin B12 deficiency, or alcohol use disorder). 9. Ischaemic stroke clearly attributable to other aetiologies. 10. Active co-infection with central nervous system opportunistic pathogens (e.g., tuberculous meningitis, cryptococcal meningitis, toxoplasmic encephalitis, or cytomegalovirus encephalitis). 11. Other central nervous system or systemic diseases causing abnormal cerebrospinal fluid parameters (including but not limited to autoimmune encephalitis, multiple sclerosis, central nervous system tumours, systemic lupus erythematosus, antiphospholipid syndrome, sarcoidosis, or systemic vasculitis). 12. Severe renal impairment (serum creatinine \>3.0 mg/dL \[265.2 μmol/L\], glomerular filtration rate \<30 mL/min/1.73 m², or on dialysis) or severe hepatic impairment (ALT or AST \>3 × upper limit of normal). 13. Severe underlying comorbidities with an expected life expectancy of \<1 year. 14. Pregnancy or lactation; or women of childbearing potential with a negative pregnancy test who decline to use effective contraception. 15. Current participation in another investigational drug or device trial. 16. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation or unable to comply with the protocol.

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)