Actively Recruiting
Early Interferon-beta Treatment for West-Nile Virus Infection
Led by Tel-Aviv Sourasky Medical Center · Updated on 2024-07-23
100
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 even life-threatening disease (neuroinvasive disease). Recent study has shown that up to 40% of WNV patients who develop neuroinvasive disease, have antibodies against Interferons (anti-Type I interferon autoantibodies), which neutralizes interferons, and could explain the development of severe disease. The investigators therefore assume that early treatment with interferon beta (the type of interferon against which most patients do not have neutralizing antibodies) could prevent the development of severe neuroinvasive WNV disease.
CONDITIONS
Official Title
Early Interferon-beta Treatment for West-Nile Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have clinical symptoms compatible with West Nile virus infection such as fever, headache, flaccid paralysis, or encephalopathy
- Diagnosis confirmed by positive anti-WNV IgM antibodies or WNV PCR from serum, urine, or cerebrospinal fluid
- Patients older than 70 years of age at higher risk for severe disease
- Patients with neuroinvasive disease including flaccid paralysis or encephalitis, regardless of age
- Immunocompromised patients of any age, including those with hematologic malignancies, recent chemotherapy, stem cell or organ transplant, use of immunosuppressants, or immunodeficiency disorders
You will not qualify if you...
- Patients younger than 18 years old
- Pregnant women
- Hypersensitivity to natural or recombinant interferon beta
- Decompensated liver disease
- Patients with neuroinvasive disease who show spontaneous improvement over more than 2 days and have a Modified Rankin Scale score below 4
- More than 8 days since onset of neurological symptoms in immunocompetent patients
- More than 10 days since onset of neurological symptoms in immunocompromised patients unless new encephalitis symptoms develop
- Patients receiving active chemotherapy or with concurrent severe viral infections
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
Research Team
D
David Hagin, MD PhD
CONTACT
D
Dania Dror, B.Nutr; MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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