Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

March 6, 2014 updated by: University of Zurich

Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)

The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.

Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.

Patients are monitored for signs of neuro- and nephrotoxicity

Study Type

Interventional

Enrollment (Anticipated)

10

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

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital of Zurich, Dept. of Pharmacology and Toxicology
        • Contact:
        • Principal Investigator:
          • Natascia Corti, MD

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:

  • male or female aged 18 years or older
  • hospitalised on the ICU
  • gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
  • clinical necessity for continuous venovenous renal replacement therapy

Exclusion Criteria:

  • History of hypersensitivity to colistin or to other polymyxins
  • Personal or family history of Myasthenia Gravis

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: colistin pharmacokinetics
Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required
Drug: Colistin
Colistin i.v. three times daily as long a necessary for infection treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC)
Time Frame: predose, and 0.5, 1, 2, 4, 6, 8 hours after administration
predose, and 0.5, 1, 2, 4, 6, 8 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sings of neurotoxicity and nephrotoxicity
Time Frame: Expected average of follow up is about 14 days.
Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support.
Expected average of follow up is about 14 days.
Sings of neurotoxicity and nephrotoxicity
Time Frame: Expected average of follow up is about 14 days.
Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. The patients will be followed for the duration of colistin administration at the dose studied.
Expected average of follow up is about 14 days.

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Natascia Corti, MD, University Hospital Zurich, Dept. of Pharmacology and Toxicology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLPKZH11
  • 213DR11032 (Other Identifier: Swissmedic)

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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