2024-520042-31-00招募中4 期
Aciclovir for HSV-2 MENingitis: A double-blinded randomised controlled trial (AMEN)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- The primary outcome in the current study is the proportion of patients with a TMS >6 at 7 days since randomisation.
研究概览
简要总结
To determine whether active treatment with (val)acyclovir is superior for treatment of viral meningitis compared with placebo assessed by number of patients with a Total Morbidity Score (TMS) >6 at 7 days after randomisation
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever)
- •Cerebrospinal fluid (CSF) pleocytosis (>4 leukocytes x 106/L)
- •HSV-2 positive by PCR of the CSF
- •Glasgow Coma Scale score of 15
- •Ability to absorb oral medications
排除标准
- •Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care
- •Systemic antiviral therapy with an antiherpetic effect for >24 hours
- •Previous enrolment into this trial
- •Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care
- •Severe immuno-compromise defined as an ongoing need for biological- or chemotherapy (e.g. natalizumab), prednisolone >20 mg/day for ≥14 days, uncontrolled HIV/AIDS, haematological malignancies, and organ transplant recipients
- •Moderate to severe concomitant genital herpes requiring systemic aciclovir
- •Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women)
- •Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels >5 times the upper limit of normal)
- •Impaired renal function (estimated glomerular filtration rate <25 mL/min)
- •Intolerance to (val)aciclovir
- •Probenecid treatment
结局指标
主要结局
The primary outcome in the current study is the proportion of patients with a TMS >6 at 7 days since randomisation.
The primary outcome in the current study is the proportion of patients with a TMS >6 at 7 days since randomisation.
次要结局
- Proportion of patients with ≤50% reduction in TMS score after 7 days compared with TMS score at randomisation
- Unfavourable outcome (E-GOS <7) and all-cause mortality at 7 days, 3 and 12 months since randomisation
- Proportion with a headache score of >2 at 7 days since randomisation
- Persisting neurological symptoms (sensory or motor nerve) at 7 days, 3 and 12 months since randomisation
- Completion of assigned treatment strategy
- Peripheral venous line complications (infection or superficial venous thrombosis) during treatment
- Duration of admission
- Severe adverse events during treatment
- Quality of life scores and cognitive evaluations (SF-36, EQ-5D-5L, Mental fatigue Scale) at 7 days as well as 3- and 12-months since randomisation
研究者
Jacob Bodilsen
Scientific
Aalborg University Hospital
研究点 (8)
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