Aciclovir Versus Placebo for HSV-2 Meningitis
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
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
Treatments tested in this trial
- Acyclovir 50 MG/ML
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Jacob Bodilsen
Lead sponsor
Aalborg University Hospital
Sponsor institution
Source ClinicalTrials.gov