- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00031512
Pleconaril Enteroviral Sepsis Syndrome
A Double-Blind, Placebo-Controlled, Virologic Efficacy Trial of Pleconaril in the Treatment of Neonates With Enteroviral Sepsis Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital - Pediatrics
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Alabama
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Birmingham, Alabama, United States, 35233-0011
- Children's of Alabama Child Health Research Unit (CHRU)
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Arkansas
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Little Rock, Arkansas, United States, 72202-3500
- University of Arkansas - Arkansas Children's Hospital Research Institute
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California
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Los Angeles, California, United States, 90095-8358
- Ronald Reagan University of California Los Angeles Medical Center
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San Diego, California, United States, 92123-4223
- Rady Children's Hospital San Diego
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Stanford, California, United States, 94305-2200
- Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
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Colorado
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Aurora, Colorado, United States, 80045-7106
- Children's Hospital Colorado - Infectious Disease
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Florida
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Gainesville, Florida, United States, 32610-0296
- University of Florida - Shands Children's Hospital
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Illinois
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Chicago, Illinois, United States, 60637-1425
- The University of Chicago - Comer Children's Hospital - Infectious Diseases
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Kentucky
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Louisville, Kentucky, United States, 40202-1821
- University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
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Louisiana
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New Orleans, Louisiana, United States, 70112-2600
- Tulane University - Tulane Medical Center - Pediatrics
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi - Children's Infectious Diseases
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Missouri
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Saint Louis, Missouri, United States, 63110-1010
- Washington University School of Medicine in St. Louis - Center for Clinical Studies
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Nebraska
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Omaha, Nebraska, United States, 68114-4108
- University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases
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New Jersey
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New Brunswick, New Jersey, United States, 08901-1766
- Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases
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New York
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Syracuse, New York, United States, 13210-2342
- SUNY Upstate Medical University Hospital - Pediatrics
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Ohio
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Columbus, Ohio, United States, 43205-2664
- Nationwide Children's Hospital - Infectious Diseases
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213-3320
- Children's Hospital of Pittsburgh of UPMC - Allergy, Immunology and Infectious Diseases
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Rhode Island
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Providence, Rhode Island, United States, 02903-4923
- Rhode Island Hospital - Pediatrics
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Tennessee
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Nashville, Tennessee, United States, 37232-0011
- Vanderbilt University - Pediatric - Infectious Diseases
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Texas
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Dallas, Texas, United States, 75390-9063
- University of Texas Southwestern Medical Center - Pediatrics
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Dallas, Texas, United States, 75235-7708
- Parkland Memorial Hospital
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Fort Worth, Texas, United States, 76104-2710
- Cook Children's Infectious Disease Services
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Galveston, Texas, United States, 77555-5302
- University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston
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San Antonio, Texas, United States, 78229-3901
- University of Texas Health Science Center San Antonio - Pediatrics - Immunology & Infectious Disease
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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: 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo.
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Placebo.
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Experimental: Pleconaril (VP63843)
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.
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5 mg/kg /dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral liquid formulation and 8.5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral suspension formulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of patients shedding virus (as detected by viral culture) from the oropharynx (i.e. throat).
Time Frame: 5 days after beginning study drug.
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5 days after beginning study drug.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change in baseline laboratory abnormalities [aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, platelets, creatinine), reflecting either resolution or progression of enteroviral disease.
Time Frame: Day 1 (at study enrollment), 3, 5, 7, 10 and 14.
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Day 1 (at study enrollment), 3, 5, 7, 10 and 14.
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Duration (in days) of total hospitalization.
Time Frame: At discharge from hospital.
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At discharge from hospital.
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Duration (in days) of shedding of virus (as detected by viral culture) from the rectum, oropharynx (i.e. throat), urine and serum.
Time Frame: Day 1 (immediately prior to first dose of study drug), Days 2, 3, 4, 5, 7, 10 and 14.
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Day 1 (immediately prior to first dose of study drug), Days 2, 3, 4, 5, 7, 10 and 14.
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Time (in days) to resolution of residual organ-related abnormalities following acute disease.
Time Frame: Day(s) from onset of acute disease
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Day(s) from onset of acute disease
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Safety.
Time Frame: After each clinical and safety evaluation during the treatment and follow-up period (through Day 180 +/- 14 days).
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After each clinical and safety evaluation during the treatment and follow-up period (through Day 180 +/- 14 days).
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Survival at two months of age.
Time Frame: 2 months.
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2 months.
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Survival at one year of age.
Time Frame: 1 year.
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1 year.
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Pleconaril pharmacokinetics.
Time Frame: Days 1, 3 and 7.
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Days 1, 3 and 7.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-018
- CASG 106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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