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

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

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

Conditions
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Infections During Organ Replacement Therapy

Intervention / Treatment
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* Other: Pharmacokinetic profiling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetic profiling in Hemodialysis<br>Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. | Other: Pharmacokinetic profiling<br>* 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.<br>|
| Experimental: Pharmacokinetic profiling in CVVH<br>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<br>* 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.<br>|
| Experimental: Pharmacokinetic profiling in MARS<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, doripenem, renal replacement therapy, MARS, organ replacement therapy