Dexamethasone in Herpes Simplex Virus Encephalitis Trial

Phase 1

• Conditions: HSV encephalitis; MedDRA version: 20.0Level: LLTClassification code 10014590Term: Encephalitis herpesSystem Organ Class: 100000013665; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004835-19-FR
• Lead Sponsor: niversity Hospital Grenoble

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-12
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Suspected encephalitis criteria:
Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours.
2.Laboratory confirmed HSV by positive PCR on CSF sample.
3.Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
4.Age = 18 years
5.Written informed consent has been given by the patient or their legal representative

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days.
2.History of hypersensitivity to corticosteroids
3.Immunosuppression secondary to:
- Known HIV infection & CD4 count under 200cell/mm3
- Biologic therapy or other immunosuppressive agents [azathioprine, methotrexate, ciclosporin]
- Solid organ transplant on immunosuppression
- Bone marrow transplant
- Currently undergoing a course of chemotherapy or radiotherapy
- Known immunodeficiency syndrome [other than HIV]
- Known haematological malignancy
4.Pre-existing indwelling ventricular devices
5.Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing = 2 unit haemoglobin drop
6.Currently on an antiretroviral regime containing rilpivirine
7.Subject under administrative or judicial control, person who are protected under the act.
8.Pregnant women, breastfeeding and parturient

Study & Design

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