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Aciclovir Versus Placebo for HSV-2 Meningitis

ConditionsHerpes Simplex 2Meningitis, Viral
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJacob Bodilsen

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever) AND

Cerebrospinal fluid (CSF) pleocytosis (>4 leukocytes x 106/L) AND

HSV-2 positive by PCR of the CSF

Glasgow Coma Scale score of 15 AND

Disqualifiers

Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care (see Glossary)20

Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care (see Glossary)21

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 recipients14,18,22

Moderate to severe concomitant genital herpes requiring systemic aciclovir

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acyclovir 50 MG/ML

    Drug

    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

    Drug

    Placebo either in IV formulation or as tablets identical to valacyclovir tablets.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Active armActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

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
3

Secondary endpoint 3 All-cause mortality

All-cause mortality

Time frame
7 days, 3 months, and 12 months since randomisation
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jacob Bodilsen

Lead sponsor

Aalborg University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: