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Home > "I" Clinical Trials Conditions > IVIG - West Nile encephalitis: Safety and Efficacy  IVIG - West Nile encephalitis: Safety and Efficacy
IVIG - West Nile encephalitis: Safety and Efficacy
For Condition: West Nile Fever
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Primary To assess and characterize the safety and tolerability of Omr-IgG-am in a population of hospitalized patients with confirmed or suspected WNV disease Secondary To assess pharmacokinetics of specific anti-West Nile antibodies following intravenous administration of Omr-IgG-am; To estimate efficacy of Omr-IgG-am in reducing morbidity and mortality, for patients with known or suspected WNV infection who receive WNV specific IVIg versus similar patients who receive either placebo; To further characterize the natural history of severe WNV infection.
Details: Investigators will assess whether Omr-IgG-am, intravenous immunoglobulin (IVIg) containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in patients with suspected or confirmed WNV disease. An initial estimation of efficacy will also be made. This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West Nile encephalitis and/or myelitis or those with confirmed diagnosis of WNV infection who are at high risk for progressing to severe neurologic disease based on age or immunosuppression. Patients will be randomized in blocks of five to receive either Omr-IgG-am, Polygam S/D (IVIG containing no anti-WNV antibodies) or saline placebo in a ratio of 3:1:1. Patients and investigators will be blinded to treatment assignments. Patients will receive a single intravenous dose of active treatment or one of two placebos. Two dosing cohorts will be accrued sequentially. The first cohort will receive 0.5 grams/kg of Omr-IgG-am or Polygam S/D or a comparable volume of saline. The second cohort will receive 1 gram/kg of either preparation or saline. All patients will be followed for safety, natural history and efficacy. A subset of patients will have pharmacokinetics of specific anti-WNV antibodies assessed following treatment. The primary endpoints are safety and tolerability following Omr-IgG-am administration. Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in confirmed WNV positive patients, and the combination of mortality and functional status at three months in both confirmed WNV-infected patients and all patients by intention to treat.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Group Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: A. Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below. New neurologic abnormality: Asymmetric extremity weakness without sensory abnormality; or Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days AND CSF examination within the previous 72 hours showing: Absence of organism on gram or fungal stain; White blood cell count; 4 per (mm)3 corrected for significant red blood cell contamination. Ratio of CSF: plasma glucose of 40 percent (CSF glucose / plasma glucose greater than or equal to 0.4). OR B. Hospitalized patients without encephalitis and /or myelitis as defined below who meet the following criteria: A positive IgM serology or PCR test for WNV in blood or cerebrospinal fluid AND Clinical illness compatible with WNV infection as defined by occurrence of greater than or equal to 3 of the following findings during the preceding less than or equal to 7 days: Diarrhea, Headache, Fever, 38 degrees Celsius, Nausea and/or vomiting, Myalgias and/or arthralgias, Nuchal rigidity, Macular or papular rash, New neurological abnormality (not suggestive of encephalitis or myelitis) AND A risk factor for the development of WNV neurologic disease as defined by: Age greater than or equal to 40 years, or Age greater than or equal to 18 years plus immunosuppression, as defined by any of the following: Hematologic malignancy; Previous diagnosis of diabetes mellitus; Chemotherapy within previous 4 weeks; Stem cell transplant recipient or solid organ transplant recipient; Taking immunosuppressive medications; including prednisone greater than or equal to .5 mg/day within the previous 4 weeks; History of human immunodeficiency virus (HIV) infection; Congenital immunodeficiency syndrome (including common variable immunodeficiency). EXCLUSION CRITERIA: - Unable to obtain valid informed consent. - History of intolerance (including anaphylaxis) to IVIg or related compounds. - Known history of IgA deficiency. - History of (or at time of study entry) hyperviscosity syndrome including but not limited to: Waldenstrom's macroglobulinemia, multiple myeloma, total white blood cell count greater than 80000/mm(3), Hematocrit greater than 55 percent, platelet count greater than 700000/mm(3). - Meets criteria of Class III or IV of the New York Heart Association Classification for congestive heart failure patients. - Serum creatinine greater than 2.5 mg/dL or requires dialysis. - Alternate explanation (as determined by the investigator) for clinical findings (such as structural brain lesion, cardiovascular accident, or other infectious disease including another flavivirus). - Pregnant or breastfeeding (negative serum or urine pregnancy test required within the previous 72 hours if the woman is not postmenopausal or has not been surgically sterilized). - Investigator's opinion that patient would be unable to adhere to protocol requirements. - Receipt of ribavirin, interferon alpha or any investigational drug for the treatment of WNV or hepatitis within 15 days prior to study entry. - Known history of hypersensitivity to maltose
Total Enrollment: 100
Location and Contact Information:
Tulane University Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
William Beaumont Hospital *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting
University of Michigan - Ann Arbor MI *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting
University of Alabama at Birmingham (CASG) *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Wayne State University *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting
Flushing Hospital Medical Center *Recruiting*
Flushing, New York, 11355
United States
Recruiting
University of Virginia Health System *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting
Indiana University-Purdue University at Indianapolis *Recruiting*
Indianapolis, Indiana, 46202-512
United States
Recruiting
St. Louis University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
The Reading Hospital and Medical Center *Recruiting*
Reading, Pennsylvania, 55
United States
Recruiting
Loyola University Medical Center *Recruiting*
Chicago, Illinois, 60626
United States
Recruiting
Louisiana State University Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
University of Texas - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting
University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting
Wilford Hall Medical Center - Lackland AFB - TX *Recruiting*
Lackland Air Force Base, Texas, 78236
United States
Recruiting
Creighton University Medical Center *Recruiting*
Omaha, Nebraska, 68178
United States
Recruiting
National Institutes of Health *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting
University of New Mexico - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting
University of California *Recruiting*
Sacramento, California, 95817
United States
Recruiting
University of Kansas *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting
University of Kentucky *Recruiting*
Lexington, Kentucky, 40506
United States
Recruiting
George Washington University - Washington DC *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting
University of Colorado - Denver CO *Recruiting*
Denver, Colorado, 80262
United States
Recruiting
University of Texas Health Science Ctr - San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
Additional Information:
Study ID Numbers: 03-107;
Study Start Date: September 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068055
Other West Nile Fever Studies:
1. IVIG - West Nile encephalitis: Safety and Efficacy
Related Studies:
Other West Nile Fever Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
IVIG - West Nile encephalitis: Safety and Efficacy
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