Clinical trial • Phase IV • Infectious Disease

Ciprofloxacin hydrochloride (ciprofloxacin) for Bacterial infection

Phase IV trial of Ciprofloxacin hydrochloride (ciprofloxacin) for Bacterial infection.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Bacterial infection
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-01-2025
First CTIS Authorization Date
24-01-2025

Trial design

Reference group: ciprofloxacin 500 mg orally twice daily or 400 mg intravenously twice daily (regular doses in patients with adequate renal function); Test group: revised reduced doses for impaired renal function - 750 mg orally once daily or 600 mg intravenously once daily.-controlled Phase IV trial across 3 sites in Netherlands.

Comparator
Reference group: ciprofloxacin 500 mg orally twice daily or 400 mg intravenously twice daily (regular doses in patients with adequate renal function); Test group: revised reduced doses for impaired renal function - 750 mg orally once daily or 600 mg intravenously once daily.
Real World Control
Yes
Target Sample Size
58
Trial Duration For Participant
3

Eligibility

Recruits 58 No vulnerable population selected; informed consent is required from participants (age ≥ 18 years)..

Vulnerable Population
No vulnerable population selected; informed consent is required from participants (age ≥ 18 years).

Inclusion criteria

  • {"criterion_text":"- being treated with ciprofloxacin intravenously (iv) or orally (po) as part of standard care - age ≥ 18 years"}
  • {"criterion_text":"- being admitted to general wards of the Amsterdam UMC – location AMC or the OLVG- location Oost or Noordwest Ziekenhuisgroep"}
  • {"criterion_text":"- informed consent is obtained"}

Exclusion criteria

  • {"criterion_text":"- 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"}
  • {"criterion_text":"- patients with cystic fibrosis (CF)"}
  • {"criterion_text":"- informed consent is not obtained"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Drug exposure in the first 24 hours of treatment (AUC0- 24)","definition_or_measurement_approach":"AUC0-24 (drug exposure in the first 24 hours of treatment); used to assess bioequivalence between test (revised reduced doses in impaired renal function) and reference (regular doses in adequate renal function) groups."}

Recruitment

Planned Sample Size
58
Recruitment Window Months
76
Consent Approach
Informed consent is required and must be obtained from participants (inclusion criterion: "informed consent is obtained"). Subject information and informed consent form documents (L1 SIS and ICF) are available for adequate and impaired renal function populations. Only adults (age ≥ 18 years) are enrolled, so no assent process for minors is indicated.

Methods

  • Recruitment of patients admitted to general wards of Amsterdam UMC – location AMC who are being treated with ciprofloxacin as part of standard care (Netherlands).
  • Recruitment of patients admitted to general wards of OLVG - location Oost who are being treated with ciprofloxacin as part of standard care (Netherlands).
  • Recruitment of patients admitted to general wards of Noordwest Ziekenhuisgroep who are being treated with ciprofloxacin as part of standard care (Netherlands).

Geography

Total Number Of Sites
3
Total Number Of Participants
58

Netherlands

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
24-01-2025
Processing Time Days
3
Number Of Sites
3
Number Of Participants
58

Sites

Site Name
OLVG
Department Name
Department of Internal Medicine, Division of Infectious Diseases
Principal Investigator Name
J.E. Stalenhoef
Principal Investigator Email
j.e.stalenhoef@olvg.nl
Contact Person Name
J.E. Stalenhoef
Contact Person Email
j.e.stalenhoef@olvg.nl
Site Name
Amsterdam UMC Stichting
Department Name
Department of Pharmacy and Clinical Pharmacology
Principal Investigator Name
R.M. van Hest
Principal Investigator Email
rm.vanhest@amsterdamumc.nl
Contact Person Name
R.M. van Hest
Contact Person Email
rm.vanhest@amsterdamumc.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Department of Internal Medicine, Division of Infectious Diseases
Principal Investigator Name
G van Twillert
Principal Investigator Email
g.twillertvan@nwz.nl
Contact Person Name
G van Twillert
Contact Person Email
g.twillertvan@nwz.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Patient organisation/association
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
CIPROFLOXACIN
Active Substance
Ciprofloxacin hydrochloride (ciprofloxacin)
Modality
Small molecule
Routes Of Administration
Oral | Intravenous
Route
Oral | Intravenous
Authorisation Status
SmPC available
Starting Dose
Test: 750 mg orally once daily or 600 mg intravenously once daily; Reference: 500 mg orally twice daily or 400 mg intravenously twice daily
Dose Levels
750 mg PO once daily; 600 mg IV once daily; 500 mg PO twice daily; 400 mg IV twice daily
Frequency
Oral: once daily (test) or twice daily (reference); IV: once daily (test) or twice daily (reference)
Maximum Dose
1500 mg per day

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