Aciclovir for treatment of meningitis caused by HSV-2 virus

Phase 1

• Conditions: Viral meningitis caused by Herpes simplex virus 2; MedDRA version: 21.1Level: LLTClassification code 10047469Term: Viral meningitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000033-41-DK
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-23
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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

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 <25 mL/min)

7.Intolerance to (val)aciclovir

8.Probenecid treatment

9.Systemic antiviral therapy with an antiherpetic effect for >24 hours

10.Previous enrolment into this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>The TMS is calculated as the sum of scores for the following symptoms:<br><br>1.Headache (0=none to 6=incapacitating)<br>2.Nuchal rigidity (0 to 4)<br>3.Photophobia (0 to 4)<br>4.Myalgia (0 to 4)<br>5.Fever (0 to 4)<br>6.Nausea (0 to 4)<br>;Timepoint(s) of evaluation of this end point: 10 days after randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of patients with <50% reduction in TMS score after 10 days compared with TMS score at randomisation.<br><br>Extended Glasgow Outcome Scale score at 10 days, 3 months and 12 months since randomisation.<br><br>Quality of life scores and cognitive evaluations at 10 days, 3 months and 12 months since randomisation.<br><br>Persisting neurological symptoms at 10 days, 3 months and 12 months since randomisation.<br><br>Completion of assigned treatment.<br><br>Peripheral venous line associated complicatoins.<br><br>Severe adverse events.;Timepoint(s) of evaluation of this end point: Plese see specification above under secondary endpoints.