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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21894

Enrollment

Registered

2020-09-03

Start date

2020-08-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Bacterial) Infectious Diseases

Interventions

1) Treatment with the revised reduced doses of ciprofloxacin for adult patients with impaired renal function. Patients with adequate renal function will be treated with the regular doses. 2) A maximum

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
1. Bioequivalence after 24-48 hours of treatment (AUC 24-48) 2. PK-PD target attainment 3. Adverse effects or toxicity related problems	—

Contacts

Public ContactSuzanne L. de Vroom

Amsterdam UMC, location Academic Medical Centre (AMC), University of Amsterdam

s.l.devroom@amc.uva.nl0031 (0)6 29189028

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)