MedPath

Pharmacodynamic breakpoints for ciprofloxacin efficacy and resistance in critically ill patients treated with continuous venovenous hemodialysis: a prospective case series study.

Completed
Conditions
Bacterial infection
Renal Insufficiency
10004018
10038430
Registration Number
NL-OMON41806
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

• Admission to the ICU of the Zaandam Medical Center during the study period
• Expected to be undergoing CVVHD for >24 h
• Treatment with ciprofloxacin for any infection or suspected infection, as judged by the attending physician.
• Age >= 18 years

Exclusion Criteria

• Cessation of renal replacement therapy before obtainment of a through sample
• No CRRT delivered during >25 % of the interval between obtainment of peak and through plasma samples.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint in our study is the theoretical pharmacodynamic breakpoint<br /><br>for efficacy, calculated by means of the following formula:<br /><br><br /><br>TP BPeff = AUC24-ss / 125 (where AUC24-ss is the estimated AUC at steady state<br /><br>during a 12 h dosing interval multiplied by 2)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary endpoint in our study is the theoretical pharmacodynamic<br /><br>breakpoint for the emergence of resistance, calculated by means of the<br /><br>following formula:<br /><br><br /><br>TP BPres = Cmax-ss / 10 (where Cmax-ss is the estimated plasma concentration<br /><br>30 minutes after ending a ciprofloxacin infusion at steady state)</p><br>
© Copyright 2025. All Rights Reserved by MedPath