Natural History of West Nile Virus Infection

NCT00069303 | Completed

• 2 other identifiers: 03030503-CC-0305
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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:
• 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.
• 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.
• Spinal MRI to see if the virus is affecting the spinal cord.

Conditions

West Nile Virus; Encephalitis; Myelitis

Keywords

West Nile Virus; Encephalitis; Virus; Mosquito; Fever; WNV; Myelitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 per mm(3) corrected for red blood cell contamination in CSF) associated with illness clinically compatible with meningitis (e.g., headache or stiff neck)
• B. West Nile Fever Cohort:
• \- Temperature greater than 38 C as documented by a health care provider.

You may not qualify if:

• Unable to obtain valid informed consent.
• Alternate explanation (as determined by the investigator) for clinical findings (such as structural brain lesion, cerebrovascular accident, or other infectious disease).
• Evidence of a microbial organism demonstrable on gram or fungal stain of CSF within four months prior to study entry.
• Investigator's opinion that patient would be unable to adhere to protocol requirements.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Mostashari F, Bunning ML, Kitsutani PT, Singer DA, Nash D, Cooper MJ, Katz N, Liljebjelke KA, Biggerstaff BJ, Fine AD, Layton MC, Mullin SM, Johnson AJ, Martin DA, Hayes EB, Campbell GL. Epidemic West Nile encephalitis, New York, 1999: results of a household-based seroepidemiological survey. Lancet. 2001 Jul 28;358(9278):261-4. doi: 10.1016/S0140-6736(01)05480-0.

  PMID: 11498211 BACKGROUND

• Nash D, Mostashari F, Fine A, Miller J, O'Leary D, Murray K, Huang A, Rosenberg A, Greenberg A, Sherman M, Wong S, Layton M; 1999 West Nile Outbreak Response Working Group. The outbreak of West Nile virus infection in the New York City area in 1999. N Engl J Med. 2001 Jun 14;344(24):1807-14. doi: 10.1056/NEJM200106143442401.

  PMID: 11407341 BACKGROUND

• Kelley TW, Prayson RA, Isada CM. Spinal cord disease in West Nile virus infection. N Engl J Med. 2003 Feb 6;348(6):564-6; author reply 564-6. doi: 10.1056/NEJM200302063480618. No abstract available.

  PMID: 12571269 BACKGROUND

MeSH Terms

Conditions

Encephalitis; Myelitis; Virus Diseases; Fever

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Central Nervous System Infections; Infections; Spinal Cord Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 22, 2003
• First Posted: September 23, 2003
• Study Start: September 16, 2003
• Study Completion: February 18, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-02-18

Locations

US (1)