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Pharmacokinetics of Ciprofloxacin in Critically Ill Patients (CAPOEIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016845
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Canisius-Wilhelmina Hospital
UMC Utrecht
Gelderse Vallei Hospital
Tergooi Hospital
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date January 9, 2017
First Posted Date January 11, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date January 1, 2017
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2017)
model for estimation of renal function that most accurately predicts ciprofloxacin clearance [ Time Frame: Day 1 and day 2 ]
Full pharmacokinetic curves will be taken on Day 1 and Day 2
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Ciprofloxacin in Critically Ill Patients
Official Title Pharmacokinetics of Ciprofloxacin in Critically Ill Patients - a Screening Study to Assess the Feasibility of Renal Function Markers to Predict Ciprofloxacin Clearance (CAPOEIRA)
Brief Summary

Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking resulting in large variation of achieved exposure and possible inadequate therapy. The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to individualize and optimize therapy for ciprofloxacin and eventually improve outcome.

In a multi-centre, observational, open-label study the investigators aim to define : the model for estimation of renal function that most accurately predicts ciprofloxacin clearance in critically ill patients.

Detailed Description

Correct estimation of glomerular filtration rate (GFR) is necessary in critically ill patients in order to asses renal function. GFR is subsequently used to derive and appropriate drug dosing of renally excreted drugs and warrant adequate dose adaptations.

It is known that estimation of GFR based on creatinine clearance is not precise, especially in populations with altered muscle mass or instable renal function, such as the Intensive Care Unit (ICU) population.

The use of combined filtration markers together, cystatin C and creatinine, can improve precision in estimating GFR (eGFR). Studies confirmed that eGFR based on both creatinine and cystatin C is more precise than eGFR creatinine or eGFR cystatin C. The equation based on both creatinine and cystatin C, the Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C (CKD-EPIcr-cys), may therefore improve eGFR and thus drug dosing in ICU patients, a population that does not reach PK/PD targets frequently.

So far little is known about drug dosing based on CKD-EPIcr-cys. Currently optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking, resulting in large variation of achieved exposure and possible inadequate therapy. The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to individualize and optimize therapy for ciprofloxacin and eventually improve outcome.

In a multi-centre, observational, open-label study the investigators aim to define the model for estimation of renal function that most accurately predicts ciprofloxacin clearance in critically ill patients.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma samples for determination of ciprofloxacin and cystatin C Urine for measuring 24h creatinine cleaurance
Sampling Method Non-Probability Sample
Study Population All patients receiving ciprofloxacin for treating a suspected or proven bacterial infection at the ICU will be included.
Condition Bacterial Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Gieling EM, Wallenburg E, Frenzel T, de Lange DW, Schouten JA, Ten Oever J, Kolwijck E, Burger DM, Pickkers P, Ter Heine R, Brüggemann RJM. Higher Dosage of Ciprofloxacin Necessary in Critically Ill Patients: A New Dosing Algorithm Based on Renal Function and Pathogen Susceptibility. Clin Pharmacol Ther. 2020 Oct;108(4):770-774. doi: 10.1002/cpt.1855. Epub 2020 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2017)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date April 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient is admitted to an ICU
  2. Subject is at least 18 years on the day of the first dosing
  3. Is managed with an arterial line or central venous catheter
  4. Is managed with an urinary catheter
  5. Is already treated with ciprofloxacin as part of routine clinical care

Exclusion Criteria:

  1. Has previously participated in this study
  2. Is on renal replacement therapy (RRT)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03016845
Other Study ID Numbers UMCN-AFK 16.07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Radboud University
Study Sponsor Radboud University
Collaborators
  • Canisius-Wilhelmina Hospital
  • UMC Utrecht
  • Gelderse Vallei Hospital
  • Tergooi Hospital
Investigators
Principal Investigator: Roger Bruggemann Radboud University
PRS Account Radboud University
Verification Date November 2017