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Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates Clinical research trials and Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates. Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates clinical trial. Subjects typically recieve the finest healthcare available for their Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates  Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
For Condition: Staphylococcal Infections
Status: Recruiting
Sponsor(s): Nabi Biopharmaceuticals ,
Synopsis: The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.
Details: Survival of Very-Low-Birth-Weight (VLBW) infants (<1500g at birth) has improved dramatically, but these patients remain subject to significant morbidity and mortality due to Staphylococcus aureus infection. S. aureus infection is a relatively common event in VLBW neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting for 15-20% of all infections in this patient population. This controlled study will assess the safety, pharmacokinetics, and preliminary efficacy of Altastaph in LBW neonates. The study will be stratified by birth weight and include up to 200 LBW neonates, 3 to 7 days of age.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: /7 Days
Genders: Both
Protocol Entry Criteria: The subject must conform to all of the following (Inclusion Criteria): - Neonate with a birth weight between 501 and 1500 grams inclusive; - Between 3 and 7 days of age, inclusive, at the time of first infusion (Day 0); - Expected to survive at least 48 hours after infusion; - Free of overt systemic infection, as determined by history, physical examination, radiologic studies, or laboratory studies including microbiology data; clinical safety tests required can be completed up to three (3) days prior to the infusion of the study product; - Direct bilirubin less than or equal to 2.0 mg/dL; - Serum creatinine level of less than or equal to 2.0 mg/dL; and - Hemodynamically stabile; if the subject is receiving cardiac support including anti-arrhythmics, pessors, or cardiac pacing, the subject must be stable on that cardiac support and be expected not to require this support indefinitely. The subject must not have any of the following (Exclusion Criteria): - Known HIV infection, as documented by maternal history or positive PCR in the infant; - Severe congenital anomaly or genetic disorder known to impact immune competence; - Prior administration of any immune globulin; - Any history, in the infant subject or its mother, of hypersensitivity or severe vasomotor reaction to any human blood product; - Cyanotic congenital heart disease; and - Central nervous system shunt
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
GaryHorwith, Study Director, Nabi Biopharmaceuticals
University of Colorado Hospital *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Gary Horwith 301-255-6910
Children's Hospital of Alabama *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Gary Horwith 301-255-6910
University of Virginia Health System *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Gary Horwith 301-255-6910
East Carolina University/ Pitt County Memorial Hospital *Recruiting*
Greenville, North Carolina, 27835-6028
United States
Recruiting Gary Horwith 301-255-6891
Westchester Medical Center *Recruiting*
Valhalla, New York, 10595
United States
Recruiting Gary Horwith 301-255-6910
Crouse Hospital *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Gary Horwith 301-255-6910
University of New Mexico Children’s Hospital *Recruiting*
Albuquerque, New Mexico, 87106
United States
Recruiting Gary Horwith 301-255-6910
St. Joseph's Hospital and Medical Center *Recruiting*
Phoenix, Arizona, 85013-3476
United States
Recruiting Gary Horwith 301-255-6910
Wilford Hall Medical Center *Recruiting*
Lackland Air Force Base, Texas, 78236
United States
Recruiting Gary Horwith 301-255-6910
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting Gary Horwith 301-255-6910
Gosilano Children’s Hospital at Strong Memorial Hospital *Recruiting*
Rochester, New York, 14642
United States
Recruiting Gary Horwith 301-255-6910
Memorial Hospital and Health System *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Gary Horwith 301-255-6891
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Gary Horwith 301-255-6910
Sunrise Children’s Hospital and Medical Center *Recruiting*
Las Vegas, Nevada, 89109
United States
Recruiting Gary Horwith 301-255-6910
VSU Health Systems *Recruiting*
Richmond, Virginia, 23298-0276
United States
Recruiting Gary Horwith 301-255-6910
Children’s Hospital Central California *Recruiting*
Madera, California, 93638
United States
Recruiting Gary Horwith 301-255-6910
Tampa General Hospital *Recruiting*
Tampa, Florida, 33606
United States
Recruiting Gary Horwith 301-255-6910
Children’s Hospital of the King’s Daughters *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Gary Horwith 301-255-6910
The Children's Hospital *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Gary Horwith 301-255-6910
University of Virginia School of Medicine *Recruiting*
Charlottesville, North Carolina, 22908
United States
Recruiting Gary Horwith 301-255-6910
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Gary Horwith 301-255-6910
Advocate Lutheran General Children’s Hospital *Recruiting*
Park Ridge, Illinois, 60068
United States
Recruiting Gary Horwith 301-255-6910
University of Connecticut Health Center, John Dempsey Hospital *Recruiting*
Farmington, Connecticut, 06030
United States
Recruiting Gary Horwith 301-255-6910
Additional Information:
Study ID Numbers: Nabi-1408;
Study Start Date: July 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066989
Other Staphylococcal Infections Studies:
1. Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
2. Safety and behavior of S. aureus Immune Globulin Intravenous(Human), [Altastaph] in patients with S. aureus bacteremia and continuing fever
3. Study to evaluate the effectiveness of StaphVAX in adults on hemodialysis
Related Studies:
Other Staphylococcal Infections Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Safety Study of an Intravenous Staphylococcus aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
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