Status:
COMPLETED
West Nile Virus Natural History
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
West Nile Virus
Eligibility:
All Genders
18+ years
Brief Summary
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 m...
Detailed Description
This is a multi-center, prospective, natural history study designed to characterize West Nile Virus (WNV) disease, including functional and neurologic outcomes, in study participants with laboratory d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00138463
Start Date
September 1 2003
End Date
December 1 2008
Last Update
November 7 2011
Active Locations (28)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2050
2
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
3
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
4
Kaiser Permanente South Bay Medical Center
Harbor City, California, United States, 90710