Natural History of West Nile Virus Infection
Nyckelord
Abstrakt
Beskrivning
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).
Datum
| Senast verifierad: | 02/17/2011 |
| Först skickat: | 09/21/2003 |
| Beräknad anmälan inlämnad: | 09/21/2003 |
| Först publicerad: | 09/22/2003 |
| Senaste uppdatering skickad: | 06/29/2017 |
| Senaste uppdatering publicerad: | 07/01/2017 |
| Faktiskt startdatum för studien: | 09/15/2003 |
| Beräknat slutfört datum: | 02/17/2011 |
Tillstånd eller sjukdom
Fas
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | - INCLUSION CRITERIA: 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: - 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 - Cerebrospinal fluid (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) B. West Nile Fever Cohort: - Temperature greater than 38 C as documented by a health care provider. EXCLUSION CRITERIA: 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. |
