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Revised dosing of Ciprofloxacin for patients with impaired renal function: a bioequivalence study
EU CTIS ID: 2024-520379-28-00
What this study is testing
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 (AUC024) is bioequivalent between both patient groups (test/reference).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 or Noordwest Ziekenhuisgroep
- informed consent is obtained
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.