Pharmacokinetics of ciprofloxacine in pediatric patients, a pilot study – SAFE PEDRUG.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004638-24-BE

Enrollment

Registered

2015-01-12

Start date

2015-03-10

Completion date

Unknown

Last updated

2018-09-03

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

Conditions

febrile urinary tract infection

Interventions

Trade Name: Ciproxine 100 mg/50 ml oplossing voor infusie Product Name: ciprofloxacine Pharmaceutical Form: Solution for infusion INN or Proposed INN: ciprofloxacin Other descriptive name: CIPROFLOXAC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: fUTI group: -Patients aged 3 months-16 years admitted to the pediatric department of University Hospital Brussels (UZB) - rectal body temperature of 38.5 °C. -Significant leukocyturia or a positive urine nitrite test in a sterile urine sample -ICF signed by both parents or official caregivers Prophylaxis group: -Patients at any age of the pediatric clinics of both University Hospital Ghent (UZG) and UZB who use cipro (at discretion of their treating physician) for preventing urinary tract infections -ICF signed by both parents or official caregivers Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnancy • Impaired renal function as defined by 2x serum creatinin level for age and sex • Epilepsy • Myasthenia gravis • Long QT-syndrome • Glucose 6 phosphatase deficiency (G6PD) • Allergy to one of the substances of cipro • Concomitant use of corticosteroids • For the prophylaxis group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigating the feasibility of a study method for pharmacokinetics (with emphasis on renal clearance) of ciprofloxacin in children. ;Secondary Objective: Results of this study will be used to set up a subsequent larger study with more subgroups of patients.;Primary end point(s): • Feasibility, shortcomings and pitfalls of our study method. • Plasma and urine concentrations of cipro at various time points after administration. • Side effects of cipro in our participants. • Effectivity of cipro;Timepoint(s) of evaluation of this end point: The expected total duration of the pilot study is 6 months	—

Measure

Time frame

Main Objective: Investigating the feasibility of a study method for pharmacokinetics (with emphasis on renal clearance) of ciprofloxacin in children. ;Secondary Objective: Results of this study will be used to set up a subsequent larger study with more subgroups of patients.;Primary end point(s): • Feasibility, shortcomings and pitfalls of our study method. • Plasma and urine concentrations of cipro at various time points after administration. • Side effects of cipro in our participants. • Effectivity of cipro;Timepoint(s) of evaluation of this end point: The expected total duration of the pilot study is 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

bimetra.clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026