Pleconaril Enteroviral Sepsis Syndrome
Public ClinicalTrials.gov record NCT00031512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Double-Blind, Placebo-Controlled, Virologic Efficacy Trial of Pleconaril in the Treatment of Neonates With Enteroviral Sepsis Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00031512
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Days to 15 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2001 (Actual)
- Primary completion
- Sep 22, 2010 (Actual)
- Completion
- Sep 15, 2012 (Actual)
- Last update posted
- Feb 5, 2024
2001 – 2012
United States locations
- U.S. sites
- 24
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama Child Health Research Unit (CHRU) | Birmingham | Alabama | 35233-0011 | — |
| University of Arkansas - Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202-3500 | — |
| Ronald Reagan University of California Los Angeles Medical Center | Los Angeles | California | 90095-8358 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123-4223 | — |
| Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases | Stanford | California | 94305-2200 | — |
| Children's Hospital Colorado - Infectious Disease | Aurora | Colorado | 80045-7106 | — |
| University of Florida - Shands Children's Hospital | Gainesville | Florida | 32610-0296 | — |
| The University of Chicago - Comer Children's Hospital - Infectious Diseases | Chicago | Illinois | 60637-1425 | — |
| University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases | Louisville | Kentucky | 40202-1821 | — |
| Tulane University - Tulane Medical Center - Pediatrics | New Orleans | Louisiana | 70112-2600 | — |
| University of Mississippi - Children's Infectious Diseases | Jackson | Mississippi | 39216-4505 | — |
| Washington University School of Medicine in St. Louis - Center for Clinical Studies | St Louis | Missouri | 63110-1010 | — |
| University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases | Omaha | Nebraska | 68114-4108 | — |
| Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases | New Brunswick | New Jersey | 08901-1766 | — |
| SUNY Upstate Medical University Hospital - Pediatrics | Syracuse | New York | 13210-2342 | — |
| Nationwide Children's Hospital - Infectious Diseases | Columbus | Ohio | 43205-2664 | — |
| Children's Hospital of Pittsburgh of UPMC - Allergy, Immunology and Infectious Diseases | Pittsburgh | Pennsylvania | 15213-3320 | — |
| Rhode Island Hospital - Pediatrics | Providence | Rhode Island | 02903-4923 | — |
| Vanderbilt University - Pediatric - Infectious Diseases | Nashville | Tennessee | 37232-0011 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235-7708 | — |
| University of Texas Southwestern Medical Center - Pediatrics | Dallas | Texas | 75390-9063 | — |
| Cook Children's Infectious Disease Services | Fort Worth | Texas | 76104-2710 | — |
| University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston | Galveston | Texas | 77555-5302 | — |
| University of Texas Health Science Center San Antonio - Pediatrics - Immunology & Infectious Disease | San Antonio | Texas | 78229-3901 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00031512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 5, 2024 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00031512 live on ClinicalTrials.gov.