Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study
Recruiting
- Conditions
- (Bacterial) Infectious Diseases
- Registration Number
- NL-OMON21894
- Lead Sponsor
- Amsterdam UMC, location AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
being treated with ciprofloxacin intravenously ( or orally ( as part of standard care
- age 18 years
- being admitted to general wards of the Ams terdam UMC location AMC or the OLVG location Oost
- 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 To assess bioequivalence of ciprofloxacin between patients with impaired renal function (eGFR 30 ml/min/1.73m2) receiving the revised reduced doses (test): 750 mg orally once daily or 600 mg intravenously once daily and patients with adequate renal function receiving regular doses (reference): 500mg orally twice daily or 400 mg intravenously twice daily by investigating whether drug exposure in the first 24 hours of treatment (AUC 0-24 is bioequivalent between both patient groups (test/reference).
- Secondary Outcome Measures
Name Time Method 1. Bioequivalence after 24-48 hours of treatment (AUC 24-48)<br>2. PK-PD target attainment <br>3. Adverse effects or toxicity related problems