Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

April 6, 2022 updated by: Florian Thalhammer, Medical University of Vienna
The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1190
        • Recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Florian Thalhammer, Prof. MD
        • Contact:
        • Sub-Investigator:
          • Matthias G Vossen, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years, able to give written informed consent
  • Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
  • Renal replacement therapy (continuous or intermittent)

Exclusion Criteria:

  • Known hypersensitivity to ceftaroline or other cephalosporins, 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
  • Ceftaroline as monotherapy for resistent species or fungal infections.
  • Other reasons oposing the study participation on the discretion of the investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IRRT
Ceftaroline levels are measured in patients receiving intermittent renal replacement therapy
Other: Ceftaroline in IRRT
Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy
Experimental: CRRT
Ceftaroline levels are measured in patients receiving continuous renal replacement therapy
Other: Ceftaroline in CRRT
Plasma levels of ceftaroline will be measured in patients receiving CRRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
Time Frame: day 15
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEFTAROLINE_RRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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