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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00138463 |
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 in the US and Canada, 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 tests, and neurological testing. There will be study visits at Days 1, 14, 30, 90, 180, and 365.
Condition |
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West Nile Virus |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Investigation of the Natural History of West Nile Virus Infection in Patients With Recently Acquired West Nile Fever or Neuroinvasive Disease |
Cerebrospinal fluid, urine, serum.
Estimated Enrollment: | 120 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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West Nile Fever Cohort
Temperature > 38 C as documented by a health care provider.
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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.
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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 documented WNV infection that have symptoms consistent with WNV neuroinvasive disease or WNV fever. The objectives of the study are to: identify and describe the mortality and morbidity, specifically neurologic and functional outcomes of patients infected with WNV; characterize the clinical course and diverse manifestations of WNV disease; and assess the kinetics of humoral immune responses to WNV infection, and to correlate these responses with clinical outcomes. The study will enroll 120 volunteers ages 18 and older. All volunteers will undergo a series of laboratory, neurologic, and physical examinations and will be followed prospectively for one year to characterize the spectrum and sequelae of WNV disease. When patients meet inclusion criteria, informed consent will be obtained, and blood will be collected to perform polymerase chain reaction (PCR), IgM, and IgG testing for WNV infection. Urine PCR for WNV will also be obtained. Upon enrollment (Day 1), a medical and surgical history, review of systems, travel, vector and blood product history will be obtained, and the baseline neurologic and clinical status will be evaluated. A clinical assessment, including a physical examination, vital signs and laboratory assessment will be performed. Based on history a pre-illness neurologic functional score will be estimated, using the Barthel Index (BI) and the Modified Rankin Scale (MRS). Investigators will assess a Day 1 functional score, using the Barthel Index (BI), the Modified Mini-Mental Status Examination (3MS), the Glasgow Outcome Score (GOS), and the Glasgow Coma Scale (GCS) if hospitalized. At study visit Day 1 ± 3, CSF will be obtained and tested for cell count, differential, protein and glucose, IgM, IgG and PCR for WNV infection. If a study participant has a lumbar puncture conducted for standard of care at any time up to 72 hours prior and up to 72 hours after study enrollment, a repeat lumbar puncture will not be necessary if an adequate aliquot of Cerebrospinal Fluid (CSF) is available for shipment to the CASG Virology Laboratory and if the required cell count, differential, protein and glucose tests were performed. A brain Magnetic Resonance Imaging (MRI) scan will be done on study visit Day 1 ± 3. If the brain MRI scan on study visit Day 1 ± 3 suggests abnormalities, a repeat MRI scan will be conducted at study visit Day 30 ± 5. If changes (either improvement or worsening) in the WNV related lesions have occurred since the MRI conducted on study visit Day 1 ± 3, a third MRI will be conducted on study visit Day 90 ± 14. Subsequent MRIs will be conducted at study visits 180 ± 21 and 365 ± 30 only if the WNV related lesions continue to improve or worsen: any two MRIs where the WNV related lesions remain stable will obviate the need for further MRI scans. There will be study visits at Day 1, Day 14 ± 3, Day 30 ± 5, Day 90 ± 14, Day 180 ± 21, and Day 365 ± 30. At these visits a brief physical examination will be done, a functional score will be assigned, and blood will be obtained for serologic WNV studies. Neurological endpoints will include the Glasgow Coma Scale (GCS) and four validated functional and cognitive scoring scales: The Barthel Index (BI); The Modified Rankin Scale (MRS); The Glasgow Outcome Score (GOS); and The Modified Mini-Mental Status Examination (3MS). MRI of spinal cord, electromyogram and nerve conduction studies will be included when available.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adults, 18 and older. Documented WNV infection that began within 4 months prior to study entry. Sites in North America.
Inclusion Criteria:
Patients, regardless of race or gender, who consent and meet entry criteria, will be enrolled.
Two cohorts of patients will be enrolled: Neuroinvasive Disease and West Nile Fever.
Cohort A: Neuroinvasive Disease Cohort:
Cohort B: West Nile Virus Fever
-Temperature greater than 38 degrees C as documented by a health care provider.
Exclusion Criteria:
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 03-114, CASG 211 |
Study First Received: | August 26, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00138463 |
Health Authority: | Canada: Ethics Review Committee; United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration |
West Nile Virus, Neuroinvasive Disease |
Virus Diseases Fever West nile virus West Nile Fever |