West Nile Virus Natural History

Completed

Conditions studied: West Nile Virus

In brief

West Nile Virus causes an infection that is spread to humans when bitten by certain types of mosquitoes. Mosquitoes become infected by biting infected birds. The purpose of this study is to find out more about West Nile Virus, which may assist in the design of better treatments. The study will be looking at the effects of the disease on individuals, specifically their nervous systems, and the outcomes of the disease. Study participants will include 120 adults ages 18 and older, who have either a fever and/or changes in their neurological (involving the brain and nervous system) status due to documented West Nile Virus infection. Study procedures will include physical examinations, blood tests, urine tests, cerebral spinal fluid (fluid in and around the brain and spinal cord) tests, and neurological (nervous system) testing. Study participants will be followed for 12 months.

Key facts

Study ID

NCT00138463

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Starts

2003-09-01

Expected to finish

2008-12-01

Last updated by the study team

2011-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients, regardless of race or gender, who consent and meet entry criteria, will be enrolled.
• Greater than or equal to 18 years of age
• Documented West Nile Virus (WNV) infection (fever or neuroinvasive disease) that began within four months prior to study entry. Illness onset is defined as the first visit to a medical care provider where compatible symptoms (see cohort A and B below) are documented.
• Local laboratory documentation of WNV infection as defined by positive immunoglobulin (Ig) M and/or polymerase chain reaction (PCR) for WNV in serum or cerebrospinal fluid (CSF) concurrent with or following illness onset.
• Qualification for A or B Cohort.
• Cohort A: Neuroinvasive Disease Cohort:
• Fever (temperature greater than 38 degrees Celsius) 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
• 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).
• Cohort B: West Nile Virus Fever Cohort:
• Temperature greater than 38 degrees Celsius 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 cerebrospinal fluid (CSF) within four months prior to study entry.
• Investigator's opinion that patient would be unable to adhere to protocol requirements.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama Medical Center — Mobile, Alabama, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Kaiser Permanente South Bay Medical Center — Harbor City, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Santa Rosa Kaiser Medical — Santa Rosa, California, United States
• Kaiser Permanente/Franklin Medical Center — Denver, Colorado, United States
• Idaho Falls Infectious Diseases, PLLC — Idaho Falls, Idaho, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Via Christi Regional Medical Center — Wichita, Kansas, United States
• Tulane University — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• National Institutes of Health — Bethesda, Maryland, United States
• Saint Louis University — St Louis, Missouri, United States
• Mercury Street Medical Group — Butte, Montana, United States
• Central Nebraska Medical Clinic — Broken Bow, Nebraska, United States
• VA Medical Center - Omaha — Omaha, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• St. George University Clara Maas Medical Center — Belleville, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Toledo — Toledo, Ohio, United States
• Memorial Hospital of RI — Pawtucket, Rhode Island, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.