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OpenTrials
Completed

NCT Number: NCT02018939

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

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

Completed

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Key information

Conditions

Infections During Organ Replacement Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacokinetic profiling

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2013
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.