Pleconaril Enteroviral Sepsis Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Enterovirus Infection

In brief

A common group of viruses that infect humans are enteroviruses. Enteroviruses produce illnesses in children which may range from very mild (summer colds) to severe (infections of the brain, liver, and heart). The purpose of this study is to determine if a new drug called pleconaril helps treat babies with enteroviral sepsis. In addition, researchers are attempting to determine a safe and effective dose of pleconaril to help babies with this disease. Infants who are 15 days or younger when diagnosed with enteroviral disease are eligible for this study. Two out of 3 babies will be randomly assigned to receive Pleconaril and the other one out of three will receive a placebo (inactive substitute). Participants will be hospitalized while receiving study medication. Babies will receive standard treatment care for their symptoms and will be observed for their medical progress. Participants may be in the study for up to 2 years.

Key facts

Study ID: NCT00031512
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 61
Starts: 2001-06-27
Expected to finish: 2012-09-15
Last updated by the study team: 2024-02-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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: a. serum glutamic pyruvic transaminase (SGPT) greater than 3 times the upper limit of normal (ULN); b. platelet count less than 100,000 and prothrombin time greater than 1.5 times ULN and positive fibrin split products; c. cardiac shortening fraction less than 25% or cardiac ejection fraction less than 50% as measured by echocardiography.

You may not qualify if…

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.

Where it is running

Children's of Alabama Child Health Research Unit (CHRU) — Birmingham, Alabama, United States
University of Arkansas - Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
Ronald Reagan University of California Los Angeles Medical Center — Los Angeles, California, United States
Rady Children's Hospital San Diego — San Diego, California, United States
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases — Stanford, California, United States
Children's Hospital Colorado - Infectious Disease — Aurora, Colorado, United States
University of Florida - Shands Children's Hospital — Gainesville, Florida, United States
The University of Chicago - Comer Children's Hospital - Infectious Diseases — Chicago, Illinois, United States
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases — Louisville, Kentucky, United States
Tulane University - Tulane Medical Center - Pediatrics — New Orleans, Louisiana, United States
University of Mississippi - Children's Infectious Diseases — Jackson, Mississippi, United States
Washington University School of Medicine in St. Louis - Center for Clinical Studies — St Louis, Missouri, United States
University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases — Omaha, Nebraska, United States
Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases — New Brunswick, New Jersey, United States
SUNY Upstate Medical University Hospital - Pediatrics — Syracuse, New York, United States
Nationwide Children's Hospital - Infectious Diseases — Columbus, Ohio, United States
Children's Hospital of Pittsburgh of UPMC - Allergy, Immunology and Infectious Diseases — Pittsburgh, Pennsylvania, United States
Rhode Island Hospital - Pediatrics — Providence, Rhode Island, United States
Vanderbilt University - Pediatric - Infectious Diseases — Nashville, Tennessee, United States
Parkland Memorial Hospital — Dallas, Texas, United States
University of Texas Southwestern Medical Center - Pediatrics — Dallas, Texas, United States
Cook Children's Infectious Disease Services — Fort Worth, Texas, United States
University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston — Galveston, Texas, United States
University of Texas Health Science Center San Antonio - Pediatrics - Immunology & Infectious Disease — San Antonio, Texas, United States
University of Alberta Hospital - Pediatrics — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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