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

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Infections During Organ Replacement Therapy

Treatments: Other: Pharmacokinetic profiling

Study type: Interventional

Funder types: Other

Identifiers

NCT02018939

DORIPENEM IN CVVH, MARS AND HD

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Pharmacokinetic profiling in Hemodialysis

Experimental group

Description:

Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.

Treatment:

Other: Pharmacokinetic profiling

Pharmacokinetic profiling in CVVH

Experimental group

Description:

Patients receiving continuous venovenous renal replacement therapy in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.

Treatment:

Other: Pharmacokinetic profiling

Pharmacokinetic profiling in MARS

Experimental group

Description:

Patients receiving liver replacement therapy (MARS) in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.

Treatment:

Other: Pharmacokinetic profiling