Pediatric Trials


CASG 106  (DMID#99-018) "Pleconaril Enteroviral Sepsis Syndrome

CLOSED TO ENROLLMENT
 

This is a double blind, placebo-controlled, virologic study of approximately 45 neonates (age less than or equal to 15) days old at time of suspected or proven enteroviral disease with severe liver, myocardial and/or consumptive coagulopathy in order to determine if administration of pleconaril will result in more rapid clearance of virus from various body sites, is safe, metabolized by the liver and if effective, as determined by clinical outcome.

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For more information on Entero Sepsis click here

If you need more information please contact the CASG Central Unit at 1-877-975-7280.

 

CASG 112 (DMID#06-0046)  "A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir in CMV Babies"

CLOSED TO ENROLLMENT
 

This study is a multi-center, prospective, international, Phase III, randomized and blinded investigation of six weeks versus six months of oral valganciclovir therapy in babies with symptomatic congenital CMV disease. Patients meeting inclusion/exclusion criteria will be offered enrollment onto the trial. The primary objective of this study is to compare the impact on hearing outcomes of six weeks versus six months of antiviral treatment with valganciclovir oral solution in infants with symptomatic congenital CMV disease. We will also evaluate the safety profile and the neurologic outcome of the drug between 6 weeks versus 6 months of therapy.

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If you need more information please contact the CASG Central Unit at 1-877-975-7280.

 

CASG 114 (DMID# 06-0059)  "Oseltamivir PK/PD Study"


 

CLOSED 

The purpose of this study is to define the pharmacokinetics of oseltamivir and oseltamivir carboxylate in children less than two years of age with confirmed influenza . These PK data will lead to a more precise dosing recommendation for this population

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For more information on the PK Study Click Here

If you need more information please contact the CASG Central Unit at 1-877-975-7280. 

 

CASG 117 (DMID# 09-0064)  "Investigative Intravenous Peramivir Study in Children"

 CLOSED

The purpose of this clinical trial is to determine the pharmacokinetics and safety of investigational intravenous peramivir in hospitalized children with influenza infection who have failed or are unable to receive oseltamivir or zanamivir therapy.

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If you need more information please contact the CASG Central Unit at 1-877-975-7280.

 

CASG 118 (DMID# 09-0036)  "Peramivir PK Sampling Study in Children"

 CLOSED

The purpose of this study is to define the pharmacokinetics of peramivir in children less than eighteen years of age who are receiving peramivir under emergency clinical use. These PK data will inform and verify the dosing recommendations that are in place for use of peramivir in children under 18 years of age.

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If you need more information please contact the CASG Central Unit at 1-877-975-7280.