Study on Aciclovir and Valaciclovir for Treating HSV-2 Meningitis in Adults

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What is this study about?

This clinical trial is focused on studying the treatment of HSV-2 meningitis, a type of viral infection that affects the protective membranes covering the brain and spinal cord. The study will use two medications: Aciclovir and Valaciclovir. These medications are commonly used to treat viral infections and will be compared to a placebo to determine their effectiveness in treating this condition.

The purpose of the study is to find out if treatment with Aciclovir or Valaciclovir is better than a placebo for patients with viral meningitis. Participants in the study will receive either the active medication or a placebo. The study will monitor the health of participants over a period of time to see how well the treatment works. The main focus will be on the number of patients who show improvement after seven days of treatment.

Throughout the study, participants will be observed for any changes in their symptoms, such as headaches or other neurological issues. The study will also look at the overall quality of life and any side effects that may occur during the treatment period. The goal is to gather information that could help improve treatment options for people with HSV-2 meningitis in the future.

1 randomisation

Upon joining the study, randomisation occurs. This means being assigned to either the group receiving the active treatment or the placebo group. The process is double-blinded, meaning neither the patient nor the researchers know which group the patient is in.

2 treatment initiation

The treatment involves either aciclovir or valaciclovir. Aciclovir is administered as a solution for infusion, which means it is given through a vein. Valaciclovir is taken orally as a film-coated tablet.

The specific dosage and frequency of administration are determined by the study protocol and are followed throughout the treatment period.

3 monitoring and assessment

During the treatment, regular monitoring occurs to assess the patient’s health and response to the medication. This includes checking for any side effects or complications, such as infections or thrombosis at the site of infusion.

The primary goal is to evaluate the Total Morbidity Score (TMS) at 7 days after randomisation. A TMS greater than 6 indicates a higher level of symptoms.

4 follow-up evaluations

Follow-up evaluations are conducted at 7 days, 3 months, and 12 months after randomisation. These assessments include checking for neurological symptoms, headache severity, and overall health outcomes.

Quality of life and cognitive function are also evaluated using specific scales such as SF-36 and EQ-5D-5L.

5 completion of treatment

The treatment strategy is completed as per the study protocol. The duration of hospital admission and any severe adverse events during the treatment are documented.

The study aims to determine if the active treatment is more effective than the placebo in reducing symptoms of viral meningitis.

Who Can Join the Study?

The patient must show symptoms that match viral meningitis, such as headache, stiff neck, sensitivity to light, or fever.
The patient must have cerebrospinal fluid (CSF) pleocytosis, which means there are more than 4 white blood cells per microliter in the fluid around the brain and spinal cord.
The patient must test positive for HSV-2 in the cerebrospinal fluid using a test called PCR.
The patient must have a Glasgow Coma Scale score of 15, which indicates they are fully awake and alert.
The patient must be able to take medications by mouth.
The patient must be within the age range of 18 to 64 years old.
Both male and female patients can participate.

Who Cannot Join the Study?

Patients with a history of HSV-2 meningitis cannot participate. HSV-2 meningitis is an infection of the protective membranes covering the brain and spinal cord, caused by the herpes simplex virus type 2.
Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Zealand University Hospital	Koege	Denmark
Hdxxjttp Hexzzboz	Hvidovre	Denmark
Hzyhukzi Hqvjrycn	Hillerød	Denmark
Huhvuq Honwhtex	Herlev	Denmark
Asvuzw Uczfdbqivq Hhvsjdzt	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.06.2025

Trial locations

Investigated drugs:

Aciclovir is a medication used to treat infections caused by certain types of viruses. In this trial, it is being tested to see if it is effective in treating viral meningitis, which is an infection of the protective membranes covering the brain and spinal cord.

Valacyclovir is a medication that is converted into aciclovir in the body. It is also being tested in this trial to determine if it is effective in treating viral meningitis. The trial aims to compare the effectiveness of valacyclovir with aciclovir in reducing the symptoms of viral meningitis.

Investigated diseases:

Herpes simplex meningitis

HSV-2 Meningitis – This disease is an inflammation of the protective membranes covering the brain and spinal cord, caused by the herpes simplex virus type 2. It typically begins with flu-like symptoms such as fever, headache, and neck stiffness. As the condition progresses, individuals may experience sensitivity to light, confusion, and sometimes seizures. The inflammation can lead to increased pressure in the brain, causing further neurological symptoms. It is more common in adults and can recur, especially in those with weakened immune systems. The disease is considered rare and requires medical attention to manage symptoms and prevent complications.

Trial ID:

2024-520042-31-00

NCT ID:

NCT05452928

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Aciclovir and Valaciclovir for Treating HSV-2 Meningitis in Adults

What is this study about?

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