Viral meningitis caused by Herpes simplex virus 2 MedDRA version: 21.1 Level: LLT Classification code 10047469 Term: Viral meningitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Aciclovir
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: Aciclovir
CAS Number: 69657-51-8
Other descriptive name: ACICLOVIR SODIUM
Conce
Sponsors
Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 24 hours 10. Previous enrolment into this trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with <50% reduction in TMS score after 10 days compared with TMS score at randomisation. Extended Glasgow Outcome Scale score at 10 days, 3 months and 12 months since randomisation. Quality of life scores and cognitive evaluations at 10 days, 3 months and 12 months since randomisation. Persisting neurological symptoms at 10 days, 3 months and 12 months since randomisation. Completion of assigned treatment. Peripheral venous line associated complicatoins. Severe adverse events.;Timepoint(s) of evaluation of this end point: Plese see specification above under secondary endpoints. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine if active treatment with intravenous aciclovir or tablet valaciclovir is superior to placebo in treatment of HSV-2 meningitis;Secondary Objective: Not applicable;Primary end point(s): Total morbidity score (TMS) >6. The TMS is calculated as the sum of scores for the following symptoms: 1.Headache (0=none to 6=incapacitating) 2.Nuchal rigidity (0 to 4) 3.Photophobia (0 to 4) 4.Myalgia (0 to 4) 5.Fever (0 to 4) 6.Nausea (0 to 4) ;Timepoint(s) of evaluation of this end point: 10 days after randomisation | — |
Countries
Australia, Denmark, France, Netherlands, Sweden
Contacts
Public ContactAalborg University Hospital
North Denmark Region
Outcome results
None listed