Status:
RECRUITING
Early Interferon-beta Treatment for West-Nile Virus Infection
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
West Nile Virus
West Nile Fever Encephalitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
West Nile virus (WNV) is a mosquito-borne virus which in majority of cases causes only self-limited disease. Despite that, in minority of cases (\~0.5%) it can infect the brain and cause severe and e...
Detailed Description
Scientific Background: West Nile virus (WNV) is a mosquito-borne neurotropic flavivirus that can infect humans and cause life-threatening disease. In recent years, WNV infections have been reported i...
Eligibility Criteria
Inclusion
- Diagnosis of WNV infection will be based on the following:
- Patients with clinical presentation suspected as compatible with WNV infection, with symptoms including elevated fever, headache or flaccid paralysis or fever with encephalopathy.
- And:
- Positive anti-WNV IgM serology / WNV PCR from either serum, urine or CSF.
- Inclusion criteria:
- We aim to focus on three patients' populations:
- Patients older than 70 years of age, who are at higher risk for the presence of neutralizing anti-Type I IFN auto-antibodies, and therefore at higher risk for developing severe neuroinvasive disease. Only patients who fulfill the diagnostic criteria above will be included.
- Patients presenting with neuroinvasive WNV disease, including either flaccid paralysis or encephalitis, independent of their age, excluding a presentation consistent with isolated aseptic meningitis (headache, fever, 6th nerve palsy). Only patients who fulfill the diagnostic criteria above will be included.
- Immunocompromised patients at any age. Immunocompromised patients will be defined as patients with hematologic malignancy (treated or untreated); chemotherapy within previous 4 weeks, stem cell transplant recipient or solid organ transplant recipient; use of any immunosuppressant drug including prednisone greater than or equal to 20 mg/day within the previous 4 weeks; primary / acquired immunodeficiency disorder. Only patients who fulfill the diagnostic criteria above will be included.
- Exclusion Criteria:
- Patients younger than 18 years old.
- Pregnant women.
- Contraindication for the administration of the drug: Hypersensitivity to natural or recombinant interferon beta, and decompensated liver disease.
- A patient with neuroinvasive disease showing consistent spontaneous improvement over a period of \> 2 days and mRS of below 4.
- More than 8 days from onset of neurological symptoms in immunocompetent patients and more than 10 days in immunocompromised patients. This time frame will be renewed if a patient with flaccid paralysis develops new onset encephalitis.
- Patients who are receiving active chemotherapy treatment or suffer concurrent severe viral infection.
Exclusion
Key Trial Info
Start Date :
July 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06510426
Start Date
July 14 2024
End Date
December 31 2025
Last Update
July 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906