Clinical trial NCT04371003: Prospective Investigation of Oxidative Stress in West Nile Virus Infection
Official title: Prospective Investigation of Oxidative Stress in West Nile Virus Infection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: West Nile Virus
West Nile Fever
West Nile Fever Encephalitis
West Nile Fever Meningitis
West Nile Meningitis
West Nile Virus Meningoencephalitis
West Nile Fever Meningoencephalitis
West Nile Fever With Neurologic Manifestation
Oxidative Stress
Keywords: Genome sequencing
composite diagnosis
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Victor Babes Hospital, Bucharest, Romania
name: Universiteit Antwerpen
First posted: 2020-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be recruited from VBH emergency and outpatient departments in Bucharest, Romania, from the onset of the WNV transmission season in 2020 until November 2023. The incidence of WNV and WNND in South-Eastern Romania was 0.5 per 100,000 inhabitants in 2016, and has been increasing steadily 35. Romania reported 277 WNND cases with 43 deaths in 2018, and 66 WNND cases with 8 deaths in 2019 3. VBH is a tertiary care facility that serves a population of 3 million people (15% of Romania's population). Its catchment area covers more than 80% of the territories in Romania that reported WNV transmission and has in recent years been the largest single medical center to care for WNV infected patients.

Brief summary: The investigator hypothesizes that oxidative stress responses to West Nile virus infection in the central nervous system determine the severity of infection and the long-term neurological, neuropsychological and functional sequelae of West Nile Neuroinvasive Disease.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent. If the clinical condition of the patient does not permit giving consent, informed consent will be obtained from the next of kin.
* Age 18 years or older
* for active cases: positive anti-WNV IGM antibodies in serum (or IgG in CSF if applicable)
* for active cases: presentation within (maximum) 7days of symptom onset
* for healthy controls: anti-WNV antibody naive (IgM and IgG in serum). The group of healthy controls will be selected to have an age similar distribution to the cases.

Exclusion Criteria:

* Evidence of active systemic infection in 3 months prior to recruitment
* Evidence of systemic inflammatory illness
* Clinical signs of neurodegenerative or neurologic disease other than WNND
* Pregnancy
* Active malignancy
* History of drug abuse

Primary outcomes:
measure: Measure the redox status
timeFrame: at recruitment, 10 days post-symptom onset and 20 days post symtom onset.
measure: Assessment of Neurologic deficits
timeFrame: At recruitment, month 3 and month 12
measure: Neuropsychologic performance
timeFrame: 20 days post-symtom onset, month 3 and month 12
measure: Longitudinal assessment of functional status Study the neurologic and neuropsychologic sequelae of WNV infection during a 12-month followup period.
timeFrame: at recruitment, month 3 and month 12
measure: MRI abnormalities
timeFrame: at recruitment, month 3 and month 12
measure: Brain iron content
timeFrame: at recruitment, month 3 and month 12
measure: Ophthalmological abnormalities
timeFrame: at recruitment, with a follow-up of clinically indicated.
measure: serum S100b concentration
timeFrame: at recruitment, 10 days post symptom onset and 20 days post symptom onset
measure: serum NSE concentration
timeFrame: at recruitment, 10 days post symptom onset and 20 days post symptom onset
Secondary outcomes:
measure: Analysis of laboratory performance characteristics (e.g. sensitivity) of WNV-specific RT-PCR and viral isolation in clinical samples, compared to composite diagnosis of WNV infection
timeFrame: 20 days
measure: Description of molecular epidemiology of infecting WNV strain(s) and viral outgrowth diagnostic performance.
timeFrame: 20 days
measure: Identification of potential genetic signatures that correlate with virulence (neuro-invasion and morbidity) in our cohort.
timeFrame: 20 days
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Victor Babes Hospital
Study officials:
affiliation: Institute of Tropical Medicine Antwerp
name: Koen Vercauteren
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Nina Hermans
role: PRINCIPAL_INVESTIGATOR
affiliation: Victor Babes Hospital, Bucharest
name: Corneliu Popescu
role: PRINCIPAL_INVESTIGATOR
References: