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Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates Clinical research trials and Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates. Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates clinical trial. Participants oftentimes recieve the finest healthcare available for their Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates  Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates
Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates
For Condition: Sepsis
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine if administration of pleconaril to critically ill neonates with enteroviral sepsis syndrome results in more rapid clearance of virus from various body sites and to determine the safety of administering pleconaril to critically ill neonates. To evaluate intersubject pharmacokinetic variability and the effect of pleconaril on clinical outcome.
Details: Enteroviral infection is a serious and important health problem in the newborn infant. Approximately 60 to 70% of infants diagnosed with enteroviral disease within the first 10 days of life acquire infection by transmission from the mother at delivery. Infected mothers usually report a febrile gastrointestinal or respiratory illness in the two-week period preceding delivery. Congenital infection is rare but often fatal. Perinatal transmission of enteroviral infections in newborn nurseries has also been implicated as an important route of disease spread in newborn infants. Postnatal transmission of enteroviral infections during seasonal peaks of enterovirus activity occurs commonly. During periods of high prevalence of enterovirus infection in the community, many potential sources of infection exist, both during and after discharge from the nursery, including the mother, other family members, and hospital staff. Management of infants and children with neonatal enteroviral meningitis and enteroviral sepsis syndrome is directed toward the symptom complex. Cultures of body fluids for bacterial and viral pathogens are performed and broad-spectrum antibiotic therapy is initiated until results of bacterial cultures are available. Acyclovir is frequently administered as well until herpes simplex virus disease is excluded. Supportive care has been the rule in management of these patients. For patients with enteroviral sepsis syndrome, intravenous gammaglobulin has been utilized in case reports and small clinical trials, but definitive proof of efficacy has not been established. As such, no specific therapeutic intervention is currently available for the management of these gravely ill neonates. Pleconaril offers the unique possibility for active intervention in the viral process of infants with enteroviral disease involving the central nervous system (CNS) and neonates with life-threatening enteroviral disease.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: /25 Days
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Your child may be eligible for this study if he or she: has been sick for 10 days or less; was 15 days old or younger when he or she became sick; weighed 3 pounds or more when he or she was born; was not more than 1 month premature, pregnancy lasted at least 8 months (32 weeks); has enteroviral disease. Your family must have a telephone or telephone where you can be contacted. EXCLUSION CRITERIA: - Your child may not be eligible for this study if he or she: has an illness that is not caused by enterovirus; has been too sick to be in a research study; has cyanotic congenital heart condition (a problem with his or her heart present at birth that causes the baby to look blue); has a known problem with his or her intestines; was born to a mother who was known to be HIV positive.
Total Enrollment: 45
Location and Contact Information:
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting
University of Southern California *Recruiting*
Los Angeles, California, 90033
United States
Recruiting
St. Joseph's Hospital - Tampa *Recruiting*
Tampa, Florida, 33607
United States
Recruiting
Children's Hospital Res Foundation - Columbus *Recruiting*
Columbus, Ohio, 43205
United States
Recruiting
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting
Cook - Fort Worth Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting
Washington University Medical Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta, T6G2B7
Canada
Recruiting
Children's Hospital & Health Center - San Diego *Recruiting*
San Diego, California, 92123
United States
Recruiting
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Connecticut Children's Medical Ctr *Recruiting*
Hartford, Connecticut, 06119
United States
Recruiting
University of Florida (Gainesville) *Recruiting*
Gainesville, Florida, 32611
United States
Recruiting
Albany Medical College *Recruiting*
Albany, New York, 12208
United States
Recruiting
Children's Hospital - Denver *Recruiting*
Denver, Colorado, 80218
United States
Recruiting
University of Alabama at Birmingham (CASG) *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Christus Santa Rosa Health Care *Recruiting*
San Antonio, Texas, 78207
United States
Recruiting
Marshall University *Recruiting*
Huntington, West Virginia, 25704
United States
Recruiting
Arkansas Children's Hospital *Recruiting*
Little Rock, Arkansas, 72202
United States
Recruiting
Schneider Children's Hospital *Recruiting*
New Hyde Park, New York, 11040
United States
Recruiting
University of Mississippi *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting
Dartmouth-Hitchcock Medical Center *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting
SUNY Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting
University of Texas Medical Branch - Galveston *Recruiting*
Galveston, Texas, 77555
United States
Recruiting
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting
Creighton University *Recruiting*
Omaha, Nebraska, 68178
United States
Recruiting
University of Florida HSC - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting
Baptist Medical Center - Jacksonville *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting
University of Texas Health Science Ctr - San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting
St. Joseph's Hospital and Medical Center *Recruiting*
Paterson, New Jersey, 07503
United States
Recruiting
Additional Information:
Study ID Numbers: 99-018;
Study Start Date: June 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031512
Other Sepsis Studies:
1. Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis.
2. Prophylactic Heparin during Xigris [Drotrecogin Alfa (Activated)] Treatment of High-Risk Severe Sepsis
3. Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-related Bloodstream Infections
4. The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients with Severe Sepsis
5. Effects of Endotoxin in Normal Human Volunteers
Related Studies:
Other Sepsis Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates
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