WithdrawnNot Applicable

Prospective Investigation of Oxidative Stress in West Nile Virus Infection

Stopped: Study proposal was not accepted for funding and therefore not further explored at this stage.

Romania0Started 2020-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure the redox status

Timeframe: at recruitment, 10 days post-symptom onset and 20 days post symtom onset.

Assessment of Neurologic deficits

Timeframe: At recruitment, month 3 and month 12

Neuropsychologic performance

Timeframe: 20 days post-symtom onset, month 3 and month 12

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

MRI abnormalities

Timeframe: at recruitment, month 3 and month 12

Brain iron content

Timeframe: at recruitment, month 3 and month 12

Ophthalmological abnormalities

Timeframe: at recruitment, with a follow-up of clinically indicated.

Trial details

NCT IDNCT04371003

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More West Nile Virus trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measure the redox status

Timeframe: at recruitment, 10 days post-symptom onset and 20 days post symtom onset.

Assessment of Neurologic deficits

Timeframe: At recruitment, month 3 and month 12

Neuropsychologic performance

Timeframe: 20 days post-symtom onset, month 3 and month 12

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

MRI abnormalities

Timeframe: at recruitment, month 3 and month 12

Brain iron content

Timeframe: at recruitment, month 3 and month 12

Ophthalmological abnormalities

Timeframe: at recruitment, with a follow-up of clinically indicated.