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NCT01027897 · ClinicalTrials.gov registry record · Phase 4

Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients

A Phase 4 study, sponsored by Emory University.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target

NCT01027897: Completed Phase 4 study, sponsored by Emory University.

NCT01027897 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01027897, a Phase 4 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study Summary

The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. The investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.

Primary Outcome

The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration

Interventions

  • DRUG Doripenem

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-04
Est. Completion 2011-12
Phase Phase 4
Emory University

1,208 total trials

What the finished NCT01027897 record still lists

NCT01027897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

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

NCT01027897 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01027897 about?

NCT01027897 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients". The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information...

What is the current status of trial NCT01027897?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2010-04. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01027897?

The interventions under investigation include: Doripenem (DRUG).

Who is sponsoring clinical trial NCT01027897?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01027897's enrollment target sits among peer trials

30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01027897, the US trial registry maintained by the National Library of Medicine. NCT01027897 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.