Pharmacokinetics of Ciprofloxacin in Pediatric Patients
- Registration Number
- NCT02598362
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in children aged 3 months - 17 years who are treated for urinary tract infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- age between 3 months and 17 years of age
- confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample.
- indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician.
Exclusion Criteria
- pregnancy
- impaired renal function as defined by 2x serum creatinine 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 oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intravenous ciprofloxacin Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician. oral ciprofloxacin Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.
- Primary Outcome Measures
Name Time Method Serum concentrations 12 hours
- Secondary Outcome Measures
Name Time Method Urine concentrations 12 hours
Trial Locations
- Locations (2)
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
Ghent University Hospital
🇧🇪Ghent, Belgium