Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.
NCT ID: NCT02018939
Last Updated: 2014-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2010-03-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pharmacokinetic profiling in Hemodialysis
Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
* Organ replacement therapy (MARS, CVVHDF or HD)
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Florian Thalhammer
a.o.Univ.-Prof. Dr.
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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References
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Vossen MG, Ehmann L, Pferschy S, Maier-Salamon A, Haidinger M, Weiser C, Wenisch JM, Saria K, Kajahn C, Jilch S, Lemmerer R, Becede M, Zeitlinger M, Kloft C, Jager W, Thalhammer F. Elimination of Doripenem during Dialysis and Pharmacokinetic Evaluation of Posthemodialysis Dosing for Patients Undergoing Intermittent Renal Replacement Therapy. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02430-17. doi: 10.1128/AAC.02430-17. Print 2018 May.
Vossen MG, Wenisch JM, Maier-Salamon A, Fritsch A, Saria K, Zuba C, Jilch S, Lemmerer R, Unger M, Jaehde U, Jager W, Thalhammer F. Doripenem Treatment during Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1687-94. doi: 10.1128/AAC.01801-15.
Other Identifiers
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DORIPENEM IN CVVH, MARS AND HD
Identifier Type: -
Identifier Source: org_study_id
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