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

NCT ID: NCT02007122

Last Updated: 2022-04-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2023-03-31

Brief Summary

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The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.

Detailed Description

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Conditions

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Infection During Renal Replacement Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IRRT

Ceftaroline levels are measured in patients receiving intermittent renal replacement therapy

Group Type EXPERIMENTAL

Ceftaroline in IRRT

Intervention Type OTHER

Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy

CRRT

Ceftaroline levels are measured in patients receiving continuous renal replacement therapy

Group Type EXPERIMENTAL

Ceftaroline in CRRT

Intervention Type OTHER

Plasma levels of ceftaroline will be measured in patients receiving CRRT

Interventions

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Ceftaroline in CRRT

Plasma levels of ceftaroline will be measured in patients receiving CRRT

Intervention Type OTHER

Ceftaroline in IRRT

Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Florian Thalhammer

Univ.-Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Florian Thalhammer, Prof. MD

Role: CONTACT

0043 1 40400 ext. 4440

Facility Contacts

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Florian Thalhammer, Prof. MD

Role: primary

0043140400

Other Identifiers

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CEFTAROLINE_RRT

Identifier Type: -

Identifier Source: org_study_id

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