To determine whether active treatment with (val)acyclovir is superior for treatment of viral meningitis compared with placebo assessed by numbers meeting a primary, objective endpoint at 7 days after randomisation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Patients are randomised to active treatment with IV acyclovir with the possibility of step-down to valacyclovir. If the treating physician prefers, initial IV treatment can be omitted and the patient can be treated with valacyclovir throughout the study period.
Placebo either in IV formulation or as tablets identical to valacyclovir tablets.
Primary endpoint (proportion with a Total Morbidity Score)
The proportion with a Total Morbidity Score (TMS) \>6 is considered treatment failure. The score is a sum of scores for headache (range 0 to 6), nuchal rigidity (range 0 to 4), photophobia (range 0 to 4), myalgia (range 0 to 4), fever (range 0 to 4), nausea (range 0 to 4). The score thus ranges from 0 to 21 with higher scores indicating more severe symptoms.
Time frame: 7 days since randomisation
Secondary endpoint 1 (Proportion of patients with ≤50% reduction of Total Morbidity Score)
Proportion of patients with ≤50% reduction of Total Morbidity Score since randomisation. Please see characterization of score under primary endpoint.
Time frame: 7 days since randomisation
Secondary endpoint 2 Extended Glasgow outcome scale score
Extended Glasgow outcome scale score. Range 1 to 8 with higher scores indicating better outcome.
Time frame: 7 days, 3 months, and 12 months since randomisation
Secondary endpoint 3 All-cause mortality
All-cause mortality
Time frame: 7 days, 3 months, and 12 months since randomisation
Secondary endpoint 4 EQ-5D-5L
EQ-5D-5L. Comprises 5 questions with an ordinal scale from 1 to 5 with higher scores indicating more morbidity. Finally, a visual analog score is filled ranging from 0 to 100 with higher scores indicating better health.
Time frame: 7 days, 3 months, and 12 months since randomisation
Secondary endpoint 5 Mental Fatigue Scale
Mental Fatigue Scale. Comprises 14 questions with scores from 0 to 3 with higher values suggesting more morbidity. A combined score \>10.5 usually suggests mental fatigue problems.
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Time frame: 7 days, 3 months, and 12 months since randomisation
Secondary endpoint 6 (SF-36)
Short Form Health Survey 36 (SF-36). Scores eight different domains from 0 to 100 with higher values indicating no disability.
Time frame: 7 days, 3 months, and 12 months since randomisation
Secondary outcome 7 neurological deficit
Any new neurological deficit reported by patient or observed during clinical examination
Time frame: 7 days, 3 months, and 12 months since randomisation
Secondary outcome 8 Completion of assigned treatment
Completion of assigned treatment (active or placebo) assessed by administered intravenous or oral treatment as signed off by nurses in hospitalized patients and pill counts for patients discharged with oral study drug.
Time frame: 7 days since randomisation
Secondary outcome 9 complications
Peripheral venous line associated complications (i.e. catheter-associated infection, thrombosis, or haemorrhage).
Time frame: 7 days since randomisation
Secondary outcome 10Severe adverse events
Severe adverse events, i.e. incident treatment-emergent serious adverse events.
Time frame: 7 days since randomisation