Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.

March 27, 2014 updated by: Florian Thalhammer, Medical University of Vienna
The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
  • Organ replacement therapy (MARS, CVVHDF or HD)

Exclusion Criteria:

  • Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
  • An expected survival of less than two days.
  • Known pregnancy
  • Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
  • Doripenem as monotherapy for resistent species or fungal infections.
  • Other reasons opposing the study participation on the discretion of the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacokinetic profiling in Hemodialysis
Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
Other: Pharmacokinetic profiling
Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.
Experimental: Pharmacokinetic profiling in CVVH
Patients receiving continuous venovenous renal replacement therapy in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
Other: Pharmacokinetic profiling
Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.
Experimental: Pharmacokinetic profiling in MARS
Patients receiving liver replacement therapy (MARS) in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
Other: Pharmacokinetic profiling
Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of organ replacement therapy on area under curve of doripenem serum concentration
Time Frame: day 15
Pharmacokinetic samples are drawn from each patient during the trial. Analysis by HPLC will be conducted after the end of the trial.
day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DORIPENEM IN CVVH, MARS AND HD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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