CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Doripenemdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01027897
NCT01027897Phase 4Completed
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Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients With Sepsis at Grady Health System

Emory University·interventional·Posted Dec 9, 2009·Updated Jan 27, 2014

In Brief

A Phase 4 clinical trial evaluating Doripenem for Sepsis. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited States
CollaboratorsOrtho-McNeil Janssen Scientific Affairs, LLC

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2009
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.6 years ago

Interventions

Doripenemdrug

Doripenem 1 gm administered over 4 hours X 3 doses