Natural History of West Nile Virus Infection
|First Received Date ICMJE||September 22, 2003|
|Last Updated Date||February 19, 2011|
|Start Date ICMJE||September 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00069303 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Natural History of West Nile Virus Infection|
|Official Title ICMJE||Investigation of the Natural History of West Nile Virus Infection in Patients With Recently Acquired West Nile Fever or Neuroinvasive Disease|
This study will examine how West Nile virus (WNV) infection affects the body. Some people infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many patients recover with no lasting effects, while a few can have long-lasting neurological damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic information on people thought to have WNV to better understand the disease.
Patients 18 years of age and older diagnosed with or suspected of having West Nile virus infection may be eligible for this study. Patients will be hospitalized until they are well enough to go home and will undergo the following tests and procedures:
Results of other tests done by the patient's local doctor (such as lumbar puncture, electroencephalogram, x-rays, etc.) will be requested. If a lumbar puncture is done, a small amount of cerebrospinal fluid will be requested for testing for WNV.
Investigation of the Natural History of West Nile Virus Infection in Patients with Recently Acquired West Nile Fever or Neuroinvasive Disease is a descriptive natural history study. Since the first reports of WNV disease in North America in 1999, geographic range has expanded, a trend that is expected to continue for the near future. There are few sequentially collected clinical, radiologic and laboratory data from patients with WNV disease. Standardized data collection tools to measure neurologic outcome have not been developed. Prospectively collected data on laboratory and clinical events associated with WNV infection are needed to bridge gaps in current knowledge of this disease and to assist with the design of better treatments. The objectives of this study are to identify and describe the mortality and morbidity, specifically the neurologic and functional outcomes of patients with confirmed WNV disease in order to characterize the clinical course and diverse manifestations, and to assess kinetics of humoral immune responses to WNV infection, correlating these responses with clinical outcomes. Eligible patients fall into two categories: those with neuroinvasive disease caused by WNV infection, and those with WNV fever who received medical attention for their illness. All subjects must have had illness onset within four months prior to enrollment and must have laboratory confirmation of the diagnosis. There will be study visits at Days 1, 14, 30, 90, 180, and 365. Evaluations will include serum and cerebrospinal fluid for determination of WNV IgM/IgG levels and PCR for WNV, urine PCR for WNV, physical examination, serial neurologic examinations, a baseline MRI scan, and four functional and cognitive assessments that have been validated in neurologic illness in adults: the Barthel Index (BI), the Modified Rankin Scale (MRS), the Glasgow Outcome Score (GOS) and the modified Mini-Mental Status Examination (3MS). The subset of study participants who develop motor weakness of an extremity (ies) will have electromyograms, nerve conduction studies and spinal MRI performed. Results from selected clinically indicated tests (done by study participants' physicians, not mandated for the study) will be recorded in the Case Record Forms (CRFs).
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||110|
|Completion Date||February 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients, regardless of race or gender, who consent and meet entry criteria will be enrolled, according to the following criteria. Note: Due to the low case incidence and the lack of validation of the neurologic scoring systems in children, enrollment will be restricted to adults. Two cohorts of patients will be enrolled: Neuroinvasive Disease and West Nile Fever.
Greater than or equal to 18 years of age.
Documented WNV infection (fever or neuroinvasive disease) that began within four months prior to study entry. Illnesss onset is defined as the first visit to a medical care provider where compatible symptoms (see cohort A or B below) are documented.
Local laboratory documentation of WNV infection as defined by positive IgM and/or PCR for WNV in serum or CSF concurrent with or following illness onset.
Qualification for Cohort A or B:
A. Neuroinvasive Disease Cohort:
- Fever (temperature greater than 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:
B. West Nile Fever Cohort:
- Temperature greater than 38 C as documented by a health care provider.
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 CSF within four months prior to study entry.
Investigator's opinion that patient would be unable to adhere to protocol requirements.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00069303|
|Other Study ID Numbers ICMJE||030305, 03-CC-0305|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP