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Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates
This study is currently recruiting patients.
| Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Sepsis |
Drug: Pleconaril (VP63843) |
Phase II |
MedlinePlus related topics: Sepsis
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Parallel Assignment
Official Title: A Double-blind, Placebo-controlled, Virologic Efficacy Trial of Pleconaril (VP63843) in the Treatment of Neonates with Enteroviral Sepsis Syndrome
Expected Total Enrollment: 45
Study start: June 1999
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
Ages Eligible for Study: up to 25 Days, Genders Eligible for Study: Both
Criteria
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Location
and Contact
Information
More Information
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| National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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