Pleconaril Enteroviral Sepsis Syndrome
Enteroviral Sepsis
About this trial
This is an interventional treatment trial for Enteroviral Sepsis focused on measuring enterovirus, enteroviral sepsis, Pleconaril, infants
Eligibility Criteria
Inclusion Criteria: Signed informed consent statement by parent or legal guardian. Age less than or equal to 15 days at time of onset of disease symptoms. Symptoms of systemic illness include but are not limited to fever, irritability, poor feeding, emesis, or diarrhea. Signs of systemic illness include, but are not limited to, jaundice, seizures, or lethargy. Onset of disease symptoms less than or equal to 10 days (240 hours) prior to administration of first dose of study medication. Birth weight greater than or equal to 1500 grams. Gestational age of greater than or equal to 32 weeks. Suspected or proven enteroviral disease. One or more of the following three conditions: serum glutamic pyruvic transaminase (SGPT) greater than 3 times the upper limit of normal (ULN); platelet count less than 100,000 and prothrombin time greater than 1.5 times ULN and positive fibrin split products; cardiac shortening fraction less than 25% or cardiac ejection fraction less than 50% as measured by echocardiography. Exclusion Criteria: Diagnosis of bacterial or non-enterovirus viral pathogen that can produce the constellation of presenting symptoms, known at the time of study enrollment. Imminent demise (estimated life expectancy less than 24 hours). Cyanotic congenital heart lesion. Alimentary tract abnormalities which may interfere with the absorption of the study drug. These include mechanical obstruction of the gastrointestinal tract, necrotizing enterocolitis, and severe ileus (the definition of which is left to the clinical judgment of the participating investigator). Infants known to be born to women who are human immunodeficiency virus (HIV) positive (but HIV testing is not required for study entry). These infants are at known risk of acquiring HIV, which would alter their immune response to other infections, including enteroviral infections. Additionally, they may be receiving antiretroviral and/or antiviral drugs during the time in which the study of pleconaril is being conducted. As such, they will be excluded if the mother's positive HIV status is known at the time of evaluation for study inclusion. If at any point following enrollment it is learned that an infant is HIV positive, however, he/she will be continued on the study protocol.
Sites / Locations
- University of Alabama - Children's of Alabama - Clinical Virology
- University of Arkansas - Arkansas Children's Hospital Research Institute
- Ronald Reagan University of California Los Angeles Medical Center
- Rady Children's Hospital San Diego
- Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
- Children's Hospital Colorado - Infectious Disease
- University of Florida - Shands Children's Hospital
- The University of Chicago - Comer Children's Hospital - Infectious Diseases
- University of Louisville School of Medicine - Kosair Childrens Hospital - Infectious Diseases
- Tulane University - Tulane Medical Center - Pediatrics
- University of Mississippi - Children's Infectious Diseases
- Washington University School of Medicine in St. Louis - Center for Clinical Studies
- University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases
- Children's Hospital and Medical Center - Infectious Disease Clinic
- Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases
- Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease
- SUNY Upstate Medical University Hospital - Pediatrics
- Nationwide Children's Hospital - Infectious Diseases
- Children's Hospital of Pittsburgh of UPMC - Allergy, Immunology and Infectious Diseases
- Rhode Island Hospital - Pediatrics
- Vanderbilt University - Pediatric - Infectious Diseases
- Parkland Memorial Hospital
- University of Texas Southwestern Medical Center - Pediatrics
- Cook Children's Infectious Disease Services
- University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston
- University of Texas Health Science Center San Antonio - Pediatrics - Immunology & Infectious Disease
- University of Alberta Hospital - Pediatrics
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Pleconaril (VP63843)
Placebo.
The first dosing cohort received 5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral liquid formulation. Subsequent dosing cohorts are receiving 8.5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral suspension formulation.