West Nile Virus Natural History

NCT00138463 | Completed

• 4 other identifiers: 03-114CASG 211N01AI30025CN01AI30025
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 28

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 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.

Conditions

West Nile Virus

Keywords

West Nile Virus, Neuroinvasive Disease

Outcome Measures

Primary Outcomes (3)

• Identify and describe the mortality and morbidity, specifically neurologic and functional outcomes of patients with West Nile Virus disease.

  Duration of Study.

• Characterize the clinical course and diverse manifestations of West Nile Virus disease.

  Duration of Study.

• Assess the kinetics of humoral immune responses to West Nile Virus infection, and correlate these responses with clinical outcomes.

  Analysis.

Study Arms (2)

West Nile Virus (WNV) Neuroinvasive Disease Cohort

Fever (temperature \> 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; other acute signs of central or peripheral neurologic dysfunction; or cerebrospinal fluid (CSF) pleocytosis associated with illness clinically compatible with meningitis.

West Nile Virus Fever Cohort

Temperature \> 38 C as documented by a health care provider.

Eligibility Criteria

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

Study Population

Adults, 18 and older, all study participants must have been diagnosed with West Nile Virus (WNV) disease within the four months prior to enrollment.

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (28)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2050, United States

Location

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Kaiser Permanente South Bay Medical Center

Harbor City, California, 90710, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California Davis Medical Center

Sacramento, California, 95816, United States

Location

Santa Rosa Kaiser Medical

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente/Franklin Medical Center

Denver, Colorado, 80205, United States

Location

Idaho Falls Infectious Diseases, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health

Bethesda, Maryland, 20892-1662, United States

Location

Saint Louis University

St Louis, Missouri, 63110-0250, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

Central Nebraska Medical Clinic

Broken Bow, Nebraska, 68822, United States

Location

VA Medical Center - Omaha

Omaha, Nebraska, 68105, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7630, United States

Location

St. George University Clara Maas Medical Center

Belleville, New Jersey, 07109, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Memorial Hospital of RI

Pawtucket, Rhode Island, 02860, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Manitoba

Winnipeg, Manitoba, R3E 3J7, Canada

Location

Related Publications (1)

• Hart J Jr, Tillman G, Kraut MA, Chiang HS, Strain JF, Li Y, Agrawal AG, Jester P, Gnann JW Jr, Whitley RJ; NIAID Collaborative Antiviral Study Group West Nile Virus 210 Protocol Team. West Nile virus neuroinvasive disease: neurological manifestations and prospective longitudinal outcomes. BMC Infect Dis. 2014 May 9;14:248. doi: 10.1186/1471-2334-14-248.

  PMID: 24884681 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid, urine, serum.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: September 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 7, 2011

Record last verified: 2010-02

Locations

CA (1); US (27)