Overview
Sponsor-declared trial summary
bacterial infection
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…
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 24 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520379-28-00
- EudraCT number
- 2019-005021-79
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Bioequivalence, Pharmacokinetic
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).
Conditions and MedDRA coding
bacterial infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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
Exclusion criteria 3
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Drug exposure in the first 24 hours of treatment (AUC0- 24)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP12479042 · ATC
- Active substance
- Ciprofloxacin Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 4500 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Dr. R.M. van Hest
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Dr. R.M. van Hest
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 58 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-01-24 | 2025-01-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024 520379 28 00 | 5 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adequate renal function | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF impaired renal function AmsterdamUMC OLVG | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF impaired renal function NWZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ciprofloxacine oraal en intraveneus | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Netherlands | Acceptable 2025-01-24
|
2025-01-24 |