Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031512
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2002-03-06
Brief Title:
Pleconaril Enteroviral Sepsis Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Virologic Efficacy Trial of Pleconaril in the Treatment of Neonates With Enteroviral Sepsis Syndrome
Status:
COMPLETED
Status Verified Date:
2012-08-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Enteroviral infection is a serious health problem in the newborn infant Approximately 60-70 of infants diagnosed with enteroviral disease within the first 10 days of life acquire their infection by transmission from the mother at the time of 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 spread of the disease in newborn infants and postnatal transmission of enteroviral infections during seasonal peaks of enterovirus activity occurs commonly Thus during periods of high prevalence of enterovirus infection in the community there are many potential sources of infection both during and after discharge from the nursery including the mother other family members and hospital staff Approximately 75 of cases of neonatal enteroviral disease carry a benign outcome with diagnosis and symptomatic treatment in non-intensive care unit settings For the remainder of patients more serious consequences can result from systemic enteroviral infection including meningoencephalitis cardiovascular collapse myocarditis or hepatitis These last two organ-specific complications carry high mortality rates Historically symptom management and supportive care have been the rule in the management of these patients No specific therapeutic intervention is currently available for the management of these gravely ill neonates The current study will evaluate the antiviral drug pleconaril as a treatment for enterovial sepsis syndrome This trial is a multi-center randomized placebo-controlled study to evaluate the virologic efficacy safety and pharmacokinetics of pleconaril in the treatment of severe enteroviral sepsis syndrome Patients will be randomized 21 to drug or placebo For enrollment into this trial infants must have evidence of severe hepatic involvement myocardial involvement andor consumptive coagulopathy Their age must be 15 days or less at the time of the onset of disease symptoms Enrollment will continue until 45 subjects with confirmed enteroviral disease have been enrolled The primary objective of this investigation is 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 Other objectives of this study are to assess the safety and pharmacokinetics of this drug in this patient population The effects of pleconaril on measures of clinical outcome also will be evaluated These include the degree of inotropic and blood product support required during the acute illness duration of hospitalization the time to resolution of residual organ injury and short-term at 2 months of age and long-term at 1 year of age survival The primary endpoint will be the percentage of patients shedding virus as detected by viral culture from the oropharynx ie throat 5 days after beginning study drug The secondary endpoints will include duration in days of shedding of virus as detected by viral culture from the oropharynx rectum urine and serum change in baseline laboratory abnormalities aspartate aminotransferase AST alanine aminotransferase ALT bilirubin platelets creatinine reflecting either resolution or progression of enteroviral disease pleconaril pharmacokinetics safety duration in days of total hospitalization survival at 2 months of age time in days to resolution of residual organ-related abnormalities following acute disease and survival at 1 year of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None