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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: Completed Phase 1 study, sponsored by Janssen Research & Development.

NCT01381848 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 52 participants
Start Date 2009-10
Est. Completion 2012-04
Phase Phase 1
Janssen Research & Development

593 total trials

What the finished NCT01381848 record still lists

NCT01381848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 1 intervention - of which Doripenem is the first listed.

NCT01381848 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01381848's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01381848, the US trial registry maintained by the National Library of Medicine. NCT01381848 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.