Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

NCT ID: NCT02081560

Last Updated: 2014-03-07

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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colistin pharmacokinetics

Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required

Group Type OTHER

Colistin

Intervention Type DRUG

Colistin i.v. three times daily as long a necessary for infection treatment

Interventions

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Colistin

Colistin i.v. three times daily as long a necessary for infection treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natascia Corti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Dept. of Pharmacology and Toxicology

Locations

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University Hospital of Zurich, Dept. of Pharmacology and Toxicology

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Natascia Corti, MD

Role: CONTACT

044 255 20 78

Facility Contacts

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Natascia Corti, MD

Role: primary

041 (0) 44 255 20 78

References

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Leuppi-Taegtmeyer AB, Decosterd L, Osthoff M, Mueller NJ, Buclin T, Corti N. Multicenter Population Pharmacokinetic Study of Colistimethate Sodium and Colistin Dosed as in Normal Renal Function in Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01957-18. doi: 10.1128/AAC.01957-18. Print 2019 Feb.

Reference Type DERIVED
PMID: 30478168 (View on PubMed)

Other Identifiers

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213DR11032

Identifier Type: OTHER

Identifier Source: secondary_id

COLPKZH11

Identifier Type: -

Identifier Source: org_study_id

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