Aciclovir for HSV-2 meningitis: A double-blind randomised controlled trial (AMEN) - AME

Aalborg University Hospital0 个研究点目标入组 150 人开始时间: 2020年1月23日最近更新: 2020年4月6日

研究概览

暂无简介。

•Adults =18 years of age admitted on suspicion of viral meningitis defined as:
•1.A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever) AND
•2.Cerebrospinal fluid (CSF) pleocytosis (>4 leukocytes x 106/L) AND
•3.Glasgow Coma Scale score of 15 AND
•4.Ability to absorb oral medications
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 40

•Patients fulfilling any of the following criteria will be excluded:
•1.Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care.
•2.Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care.
•3.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 (see glossary), haematological malignancies, and organ transplant recipients.
•4.Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women)
•5.Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels >5 times the upper limit of normal)
•6.Impaired renal function (estimated glomerular filtration rate <25 mL/min)
•7.Intolerance to (val)aciclovir
•8.Probenecid treatment
•9.Systemic antiviral therapy with an antiherpetic effect for >24 hours
•10.Previous enrolment into this trial

发起方