Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081560
• Other study ID #: COLPKZH11
• Secondary ID: 213DR11032
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2014
• Last updated: March 6, 2014
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: March 2014
• Source: University of Zurich
• Contact: Natascia Corti, MD
• Phone: 044 255 20 78
• Email: natascia.corti[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich, Dept. of Pharmacology and Toxicology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)		predose, and 0.5, 1, 2, 4, 6, 8 hours after administration	Yes
Secondary	Sings of neurotoxicity and nephrotoxicity	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.	Yes
Secondary	Sings of neurotoxicity and nephrotoxicity	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.	Yes