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NCT01381848 · ClinicalTrials.gov registry record · Phase 1
A Study of Doripenem in Infants Less Than 12 Weeks of Age
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01381848 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 52 participants.
The verdict
NCT01381848, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will also be assessed.
Interventions
- DRUG Doripenem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01381848
The ClinicalTrials.gov registry entry for NCT01381848 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Doripenem is the first listed.
NCT01381848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01381848 about?
NCT01381848 is a clinical study titled "A Study of Doripenem in Infants Less Than 12 Weeks of Age". The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment...
What is the current status of trial NCT01381848?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2009-10. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01381848?
The interventions under investigation include: Doripenem (DRUG).
Who is sponsoring clinical trial NCT01381848?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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