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Aciclovir for HSV-2 MENingitis: A double-blinded randomised controlled trial (AMEN)
EU CTIS ID: 2024-520042-31-00
What this study is testing
To determine whether active treatment with (val)acyclovir is superior for treatment of viral meningitis compared with placebo assessed by number of patients with a Total Morbidity Score (TMS) >6 at 7 days after randomisation
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever)
- Cerebrospinal fluid (CSF) pleocytosis (>4 leukocytes x 106/L)
- HSV-2 positive by PCR of the CSF
- Glasgow Coma Scale score of 15
- Ability to absorb oral medications
You likely can't join if
- Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care
- Systemic antiviral therapy with an antiherpetic effect for >24 hours
- Previous enrolment into this trial
- Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care
- 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, haematological malignancies, and organ transplant recipients
- Moderate to severe concomitant genital herpes requiring systemic aciclovir
See the full eligibility criteria
- A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever)
- Cerebrospinal fluid (CSF) pleocytosis (>4 leukocytes x 106/L)
- HSV-2 positive by PCR of the CSF
- Glasgow Coma Scale score of 15
- Ability to absorb oral medications
- Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care
- Systemic antiviral therapy with an antiherpetic effect for >24 hours
- Previous enrolment into this trial
- Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care
- 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, haematological malignancies, and organ transplant recipients
- Moderate to severe concomitant genital herpes requiring systemic aciclovir
- Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women)
- Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels >5 times the upper limit of normal)
- Impaired renal function (estimated glomerular filtration rate <25 mL/min)
- Intolerance to (val)aciclovir
- Probenecid treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.