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

Phase 1

Conditions: febrile urinary tract infection
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-004638-24-BE

Lead Sponsor: Ghent University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>•Plasma and urine concentrations of cipro at various time points after administration. <br>•Side effects of cipro in our participants.<br>•Effectivity of cipro;Timepoint(s) of evaluation of this end point: The expected total duration of the pilot study is 6 months

Secondary Outcome Measures