Pharmacokinetics of Ciprofloxacin in Critically Ill Patients
CAPOEIRA
1 other identifier
observational
40
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
4 active sites
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
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedOctober 19, 2020
November 1, 2017
1.2 years
January 9, 2017
October 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
model for estimation of renal function that most accurately predicts ciprofloxacin clearance
Full pharmacokinetic curves will be taken on Day 1 and Day 2
Day 1 and day 2
Eligibility Criteria
All patients receiving ciprofloxacin for treating a suspected or proven bacterial infection at the ICU will be included.
You may qualify if:
- Patient is admitted to an ICU
- Subject is at least 18 years on the day of the first dosing
- Is managed with an arterial line or central venous catheter
- Is managed with an urinary catheter
- Is already treated with ciprofloxacin as part of routine clinical care
You may not qualify if:
- Has previously participated in this study
- Is on renal replacement therapy (RRT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Canisius-Wilhelmina Hospitalcollaborator
- UMC Utrechtcollaborator
- Gelderse Vallei Hospitalcollaborator
- Tergooi Hospitalcollaborator
Study Sites (4)
Ziekenhuis Gelderse Vallei
Ede, Netherlands
CWZ
Nijmegen, Netherlands
Radboudumc
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Related Publications (1)
Gieling EM, Wallenburg E, Frenzel T, de Lange DW, Schouten JA, Ten Oever J, Kolwijck E, Burger DM, Pickkers P, Ter Heine R, Bruggemann 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.
PMID: 32298468RESULT
Related Links
Biospecimen
plasma samples for determination of ciprofloxacin and cystatin C Urine for measuring 24h creatinine cleaurance
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Bruggemann
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2017
First Posted
January 11, 2017
Study Start
January 1, 2017
Primary Completion
March 1, 2018
Study Completion
April 1, 2018
Last Updated
October 19, 2020
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share