Revised dosing recommendations of the antibiotic ciprofloxacin for patients with impaired renal function: a study investigating whether drug exposure is comparable between patients with impaired renal function receiving the revised reduced doses and patients with adequate renal function receiving regular doses.

Phase 1

• Conditions: Ciprofloxacin exposure in patients treated for a bacterial infection.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-005021-79-NL
• Lead Sponsor: Amsterdam UMC - location Academic Medical Centre (AMC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-10
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 or the OLVG- location Oost
- informed consent is obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

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 clinical trial of medicinal product
• Study Design: Not specified