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NCT00031512 · ClinicalTrials.gov registry record · Phase 2
Pleconaril Enteroviral Sepsis Syndrome
A Phase 2 study of Enterovirus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 20
- Study locations
NCT00031512 is a Phase 2 study of Enterovirus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 61 participants. The trial reports 20 study locations across 18 states.
The verdict
NCT00031512, a Phase 2 study of Enterovirus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Pleconaril
Study Locations (20)
California
- Ronald Reagan University of California Los Angeles Medical Center - Los Angeles
- Rady Children's Hospital San Diego - San Diego
- Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases - Stanford
Alabama
- Children's of Alabama Child Health Research Unit (CHRU) - Birmingham
Arkansas
- University of Arkansas - Arkansas Children's Hospital Research Institute - Little Rock
Colorado
- Children's Hospital Colorado - Infectious Disease - Aurora
Florida
- University of Florida - Shands Children's Hospital - Gainesville
Illinois
- The University of Chicago - Comer Children's Hospital - Infectious Diseases - Chicago
Kentucky
- University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases - Louisville
Louisiana
- Tulane University - Tulane Medical Center - Pediatrics - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2001-06-27 |
| Est. Completion | 2012-09-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031512
The ClinicalTrials.gov registry entry for NCT00031512 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Enterovirus Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00031512 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00031512 about?
NCT00031512 is a clinical study titled "Pleconaril Enteroviral Sepsis Syndrome". 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 babie...
What is the current status of trial NCT00031512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2001-06-27. Estimated completion is 2012-09-15.
What conditions does trial NCT00031512 study?
This clinical trial studies the following conditions: Enterovirus Infection.
What interventions are being tested in trial NCT00031512?
The interventions under investigation include: Placebo (OTHER), Pleconaril (DRUG).
Who is sponsoring clinical trial NCT00031512?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00031512 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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