Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study.

Phase 4

Recruiting

• Conditions: 10004018; 10038430; Bacterial infections; inflammation

• Registration Number: NL-OMON52449
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

- being treated with ciprofloxacin intravenously (iv) or orally (po) as part of
standard care
- age >= 18 years
- being admitted to general wards of the Amsterdam UMC - location AMC, the
OLVG- location Oost or Noordwest Ziekenhuisgroep location Alkmaar
- informed consent is obtained

Exclusion Criteria

- receiving renal replacement therapy (i.e. haemodialysis, peritoneal dialysis,
continuous venovenous hemofiltration or another way of renal replacement
therapy), during the first 48 hours of treatment with ciprofloxacin
- patients with cystic fibrosis (CF)
- informed consent is not obtained

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Drug exposure in the first 24 hours of treatment (AUC0-24) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Drug exposure after 24-48 hours of treatment (AUC24-48)<br /><br>2) Attainment of relevant PK-PD targets:<br /><br>· AUC / MIC >= 125<br /><br>· peak concentration (Cmax) / MIC >= 8<br /><br>3) Adverse effects or toxicity-related problems possibly attributed to<br /><br>treatment with ciprofloxacin</p><br>