CompletedNot Applicable

Natural History of West Nile Virus Infection

United States110 participantsStarted 2003-09-16

Plain-language summary

This study will examine how West Nile virus (WNV) infection affects the body. Some people infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many patients recover with no lasting effects, while a few can have long-lasting neurological damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic information on people thought to have WNV to better understand the disease. Patients 18 years of age and older diagnosed with or suspected of having West Nile virus infection may be eligible for this study. Patients will be hospitalized until they are well enough to go home and will undergo the following tests and procedures: * Medical history and physical examination: A thorough history and physical examination will be done on the first day of the study. Then, brief physical exams, including measures of blood pressure, heart rate, breathing rate, and temperature, will be done during each day of hospitalization and at every follow-up clinic visit (at 2 weeks and at 1, 3, and 6 months). * Blood tests: Blood samples will be collected on the first day of the study, at day 7, at hospital discharge, and at follow-up visits to determine if virus remains in the blood and how it is affecting the body. * Magnetic resonance imaging (MRI): MRI scans will be done within 72 hours of beginning the study and 1 month after that. This test uses a strong magnetic field and radio waves to produce images of the brain that might show abnormalities in the brains of patients with WNV and reveal whether the abnormalities can predict how an individual will recover. For the procedure, the patient lies on a table that is moved into the narrow tunnel-like scanner. During the procedure, a contrast agent that brightens the images is injected through a catheter placed in an arm vein. * Neurological examination and neurological function tests: Participants will be tested to see if the West Nile virus has affected their thinking and ability to perform normal daily activities. These tests will be done at the start of the study, on days 3 and 7 (also days 2, 4, 5, and 6 if patients are still in the hospital), at discharge, and at follow-up visits. The tests involve answering a number of questions and performing simple tasks, such as squeezing a hand or lifting a foot. * Patients who develop weakness in their arms or legs will also have the following studies: 1. Electromyography (EMG) to study the electrical activity of the muscle. For this test, needles are placed into a muscle to record the electrical activity at that site. 2. Nerve conduction studies to measure how well the nerves are working. A small charge of electricity is delivered to a nerve in the affected limb, triggering a muscle to tighten or bend. Small wire electrodes are attached to the skin to measure the time is takes for the nerve to move the electrical current from one part of the limb to another. 3. Spinal MRI to see if the virus is affecting the spinal cord. Results of other tests done by the patient's local doctor (such as lumbar puncture, electroencephalogram, x-rays, etc.) will be requested. If a lumbar puncture is done, a small amount of cerebrospinal fluid will be requested for testing for WNV.

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: Patients, regardless of race or gender, who consent and meet entry criteria will be enrolled, according to the following criteria. Note: Due to the low case incidence and the lack of validation of the neurologic scoring systems in children, enrollment will be restricted to adults. Two cohorts of patients will be enrolled: Neuroinvasive Disease and West Nile Fever. Greater than or equal to 18 years of age. Documented WNV infection (fever or neuroinvasive disease) that began within four months prior to study entry. Illnesss onset is defined as the first visit to a medical care provider where compatible symptoms (see cohort A or B below) are documented. Local laboratory documentation of WNV infection as defined by positive IgM and/or PCR for WNV in serum or CSF concurrent with or following illness onset. Qualification for Cohort A or B: A. Neuroinvasive Disease Cohort: \- Fever (temperature greater than 38 C) documented by a health care provider AND: at least one of the following, as documented by a health care provider and in the absence of a more likely clinical explanation: * Acutely altered mental status (e.g., disorientation, obtundation, stupor, or coma), * Other acute signs of central or peripheral neurologic dysfunction (e.g., paresis or paralysis, nerve palsies, sensory deficits, abnormal reflexes, generalized convulsions, or abnormal movements), or * Cerebrospinal fluid (CSF) pleocytosis (white blood cell count greater than or equal to 4 …

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.

Trial details

NCT IDNCT00069303

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeOBSERVATIONAL

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