Protocol Number: 03-CC-0305

Title:

Investigation of the Natural History of West Nile Infection in Patients with, or at Risk for Progression to West Nile Virus Encephalitis and/or Myelitis

Number:

03-CC-0305

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:

a. 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.

b. 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.

c. 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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

In order to participate in this clinical trial, all patients (or legal representatives) must provide written informed consent. Only patients meeting entry criteria will be enrolled. Eligible subjects must fall into one of two categories:

Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below:

New neurologic abnormality:

-Asymmetric extremity weakness without sensory abnormality; or

-Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days.

AND

CSF examination within the previous 72 hours showing:

-Absence of organism on gram or fungal stain;

-White blood cell count greater than or equal to 4 mm(3) corrected for significant red blood cell contamination;

-Ratio of CSF: plasma glucose of greater than or equal to 40% (CSF glucose/plasma glucose greater than or equal to 0.4).

OR

Hospitalized patients without encephalitis and/or myelitis as defined below who meet the following criteria:

A positive IgM serology or PCR test for WNV in blood or cerebrospinal fluid,

AND

Clinical illness compatible with WNV infection as defined by occurrence of greater than or equal to 3 of the following findings during the preceding less than or equal to 7 days:

-Diarrhea

-Headache

-Fever greater than 38 degrees C

-Nausea and/or vomiting

-Myalgias and/or arthralgias

-Nuchal rigidity

-Macular or popular rash

-New neurological abnormality (not suggestive of encephalitis or myelitis)

AND

A risk factor for the development of WNV neurologic disease as defined by:

Age greater than or equal to 40 years, or

Age greater than or equal to 18 years plus immunosuppression, as defined by any of the following:

-Hematologic malignancy;

-Previous diagnosis of diabetes mellitus;

-Chemotherapy within previous 4 weeks;

-Stem cell transplant recipient or solid organ transplant recipient;

-Taking immunosuppressive medications, including prednisone greater than or equal to 7.5 mg/day within the previous 4 weeks;

-History of human immunodeficiency syndrome (including common variable immunodeficiency).

EXCLUSION CRITERIA:

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).

Investigator's opinion that patient would be unable to adhere to protocol requirements.

Special Instructions: Currently Not Provided

Keywords:

West Nile Virus

Encephalitis

Virus

Mosquito

Fever

Recruitment Keywords:

West Nile Virus

WNV

Encephalitis

Myelitis

Fever

Conditions:

West Nile Virus

Encephalitis

Myelitis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

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.

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.

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. PMID: 12571269

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