Colistin Pharmacokinetics in Continuous Renal Replacement Therapy
Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 27, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMarch 7, 2014
March 1, 2014
1.7 years
February 27, 2014
March 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the curve (AUC)
predose, and 0.5, 1, 2, 4, 6, 8 hours after administration
Secondary Outcomes (2)
Sings of neurotoxicity and nephrotoxicity
Expected average of follow up is about 14 days.
Sings of neurotoxicity and nephrotoxicity
Expected average of follow up is about 14 days.
Study Arms (1)
colistin pharmacokinetics
OTHERIntravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required
Interventions
Colistin i.v. three times daily as long a necessary for infection treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of hypersensitivity to colistin or to other polymyxins
- Personal or family history of Myasthenia Gravis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Zurich, Dept. of Pharmacology and Toxicology
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 30478168DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natascia Corti, MD
University Hospital Zurich, Dept. of Pharmacology and Toxicology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 7, 2014
Study Start
November 1, 2013
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
March 7, 2014
Record last verified: 2014-03