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NCT00113191 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
A NA study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- NA
- Development phase
- 2,000
- Enrollment target
NCT00113191 is a NA study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 2,000 participants.
The verdict
NCT00113191, a NA study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,000 participants
- Enrollment target
Study Summary
The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth. Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.
Interventions
- DRUG Veronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2004-05 |
| Est. Completion | 2006-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113191
The ClinicalTrials.gov registry entry for NCT00113191 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Veronate is the first listed.
NCT00113191 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00113191 about?
NCT00113191 is a clinical study titled "Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants". The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth. Babies are enrolled between Day ...
What is the current status of trial NCT00113191?
This trial is currently completed. It is a NA study. The enrollment target is 2,000 participants. The study started on 2004-05. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00113191?
The interventions under investigation include: Veronate (DRUG).
Who is sponsoring clinical trial NCT00113191?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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