Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138463
Status:
COMPLETED
Last Update Posted:
2011-11-06
First Post:
2005-08-26
Brief Title:
West Nile Virus Natural History
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Investigation of the Natural History of West Nile Virus Infection in Patients With Recently Acquired West Nile Fever or Neuroinvasive Disease
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 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 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 a proposed sample size 120 study participants ages 18 and older All study participants 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 immunoglobulin 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 BI the Modified Mini-Mental Status Examination 3MS the Glasgow Outcome Score GOS and the Glasgow Coma Scale GCS if hospitalized and recorded answers to questions abstracted from the MRS on the day of entry into the study At study visit Day 1 3 cerebrospinal fluid 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 CSF is available for shipment to the Collaborative Antiviral Study Group 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 GCS and 4 validated functional and cognitive scoring scales The BI MRS GOS and 3MS MRI of spinal cord electromyogram and nerve conduction studies will be included when available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASG 211 | None | None | None |
| N01AI30025C | None | None | None |