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

Phase 3

Completed

• Conditions: Infections During Organ Replacement Therapy
• Interventions: Other: Pharmacokinetic profiling

• Registration Number: NCT02018939
• Lead Sponsor: Medical University of Vienna

Brief Summary

The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic profiling in Hemodialysis	Pharmacokinetic profiling	Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
Pharmacokinetic profiling in CVVH	Pharmacokinetic profiling	Patients receiving continuous venovenous renal replacement therapy in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
Pharmacokinetic profiling in MARS	Pharmacokinetic profiling	Patients receiving liver replacement therapy (MARS) in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria