Dexamethasone in Herpes Simplex Virus Encephalitis Open label Randomized Controlled Trial with an Observer-blinded evaluation at 6 months - DexEnceph

niversity Hospital Grenoble0 个研究点开始时间: 2017年9月12日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•1.Suspected encephalitis criteria:
•Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours.
•2.Laboratory confirmed HSV by positive PCR on CSF sample.
•3.Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
•4.Age = 18 years
•5.Written informed consent has been given by the patient or their legal representative
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1.Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days.
•2.History of hypersensitivity to corticosteroids
•3.Immunosuppression secondary to:
•- Known HIV infection & CD4 count under 200cell/mm3
•- Biologic therapy or other immunosuppressive agents [azathioprine, methotrexate, ciclosporin]
•- Solid organ transplant on immunosuppression
•- Bone marrow transplant
•- Currently undergoing a course of chemotherapy or radiotherapy
•- Known immunodeficiency syndrome [other than HIV]
•- Known haematological malignancy
•4.Pre-existing indwelling ventricular devices
•5.Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing = 2 unit haemoglobin drop
•6.Currently on an antiretroviral regime containing rilpivirine
•7.Subject under administrative or judicial control, person who are protected under the act.
•8.Pregnant women, breastfeeding and parturient

发起方

niversity Hospital Grenoble